[Federal Register Volume 63, Number 69 (Friday, April 10, 1998)]
[Proposed Rules]
[Pages 17744-17771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9486]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 26
[Docket No. 95N-0185]
RIN 0910-ZA11
Mutual Recognition of the Food and Drug Administration and
European Community Member State Conformity Assessment Procedures;
Pharmaceutical GMP Inspection Reports, Medical Device Quality System
Evaluation Reports, and Certain Medical Device Premarket Evaluation
Reports
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations pursuant to an international agreement that is expected
to be concluded between the United States and the European Community
(EC) (Ref. 1). Under the terms of that agreement, FDA may normally
endorse good manufacturing practice (GMP) inspection reports for
pharmaceuticals provided by equivalent EC Member State regulatory
authorities and medical device quality system evaluation reports and
certain medical device premarket evaluation reports provided by
equivalent conformity assessment bodies. FDA is taking this action to
enhance its ability to ensure the safety and efficacy of
pharmaceuticals and medical devices through more efficient and
effective utilization of its regulatory resources. The agency is
requesting comments on the proposed rule.
DATES: Comments by May 11, 1998. Comments must be received by the
Dockets Management Branch (address below) by 4:30 p.m. Eastern Standard
Time on May 11, 1998.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857, fax 301-594-3215.
FOR FURTHER INFORMATION CONTACT: Merton V. Smith, Office of
International Affairs (HFG-1), Office of External Affairs, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
0910, or E-mail: ``MSmith@bangate.fda.gov''.
SUPPLEMENTARY INFORMATION:
I. Background and History
On June 20, 1997, the United States and the EC concluded
negotiations of an agreement entitled ``Agreement on Mutual Recognition
between the United States of America and the European Community'' (also
called ``the MRA''). The MRA includes two sectoral annexes covering
products regulated by FDA. The medical device sectoral annex covers
medical device quality system-related inspection reports and premarket
evaluation reports. The pharmaceutical GMP sectoral annex covers
pharmaceutical GMP inspection reports. The MRA also includes sectoral
annexes covering products regulated by other U.S. regulatory agencies,
including telecommunication equipment, electromagnetic compatibility,
electrical safety, and recreational craft. Finally, the MRA includes an
``umbrella'' agreement that contains general provisions applicable
[[Page 17745]]
to the operation of all of the sectoral annexes.
At the conclusion of negotiations, the United States and the EC
agreed to submit the text of the MRA to their respective authorities to
complete the necessary procedures for approval and implementation (Ref.
2). For FDA, the procedures include publishing this proposed rule for
public comment.
In this document, FDA has published relevant provisions of the two
FDA sectoral annexes and the umbrella agreement, some of which create
binding obligations. FDA will review all comments and will consider
those comments addressing its binding obligations under the agreement.
II. Statutory Authority
FDA has the authority to enter into and execute the MRA under the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 et seq.)
and the Public Health Service Act (the PHS Act) (42 U.S.C. 201 et
seq.). For drugs and medical devices, section 510(i)(3) of the act (21
U.S.C. 360(i)(3)) provides authority for FDA to enter into the MRA.
Section 510(i)(3) of the act provides that:
The Secretary [FDA by delegation] is authorized to enter into
cooperative arrangements with officials of foreign countries to
ensure that adequate and effective means are available for purposes
of determining, from time to time, whether drugs or devices
manufactured, prepared, propagated, compounded, or processed by an
establishment * * * [described in this section], if imported or
offered for import into the United States, shall be refused
admission on any of the grounds set forth in section 801(a).
(Ref. 3).
The MRA and the pharmaceutical and medical device annexes represent
cooperative arrangements with officials from foreign countries. The
purpose of these arrangements is, among other things, to ensure FDA has
adequate and effective means to determine whether drugs or devices
offered for import are adulterated, misbranded, or in violation of
section 505 of the act (21 U.S.C. 355) (Ref. 4). FDA's authority to
make these determinations is found at section 801(a) of the act (21
U.S.C. 381(a)).
Section 803(b) of the act (21 U.S.C. 383(b)) provides FDA with
authority to enter into the medical device sectoral annex. That section
authorizes FDA to enter into agreements with foreign countries to
facilitate commerce in medical devices, consistent with the provisions
of the act. Such agreements are to encourage the mutual recognition of
GMP regulations relating to devices, as well as other regulations and
testing protocols determined by the Secretary (FDA by delegation) to be
appropriate.
Additional support for FDA authority to enter into this MRA is
found in the PHS Act. Under section 307 of the PHS Act (42 U.S.C.
242l), the Secretary of Health and Human Services (FDA by delegation)
has authority ``to participate with other countries in cooperative
endeavors'' in biomedical research and health care technology. In
addition, the Secretary of Health and Human Services (FDA by
delegation) has authority under section 301 of the PHS Act (42 U.S.C.
241) to ``cooperate with, and render assistance to other appropriate
public authorities * * * in the conduct of * * * investigations * * *
relating to the * * * prevention of physical and mental diseases and
impairments of man * * * .'' The cooperative activities between FDA and
the EC set forth in the MRA and this proposed regulation, fall within
FDA's delegated authority under these sections of the PHS Act.
Finally, a provision of the recently enacted FDAMA provides
authority for FDA to participate in MRA activities. Section 410 of
FDAMA authorizes FDA to ``support the Office of the United States Trade
Representative, in consultation with the Secretary of Commerce, in
efforts to move toward the acceptance of mutual recognition agreements
relating to the regulation of drugs, biological products, [and] devices
* * * and the regulation of good manufacturing practices, between the
European Union and the United States'' (Ref. 5). During negotiation of
this MRA, officials from FDA, the Office of the United States Trade
Representative, and the Department of Commerce participated in
activities in an effort to move toward acceptance of a mutual
recognition agreement.
III. Environmental Impact
The agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
IV. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866, under the Regulatory Flexibility Act (Pub. L. 96-354, as
amended by Pub. L. 104-121), and under the Unfunded Mandates Reform Act
(Pub. L. 104-4). Executive Order 12866 directs agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The Unfunded Mandates Reform Act requires agencies
to prepare an assessment of anticipated costs and benefits before
enacting any rule that may result in an expenditure by State, local and
tribal governments, in the aggregate, or by the private sector, of
$100,000,000 (adjusted annually for inflation) in any one year.
The agency believes that this proposed rule is consistent with the
regulatory philosophy and principles identified in the Executive Order
and in these two statutes. Through this regulation, the agency is
proposing to set out requirements through which it may normally endorse
certain conformity assessment procedure reports. Such reports would be
provided by equivalent EC Member State regulatory authorities for
manufacturing site inspections to ascertain conformity with
pharmaceutical GMP's and by equivalent conformity assessment bodies for
quality system audits and certain medical device premarket evaluations.
Obtaining conformity assessment information in the manner described in
the proposed rule is inherently more efficient and cost-effective than
the existing approach, where additional inspection efforts by FDA in
foreign countries are necessary because foreign regulatory systems have
not been found equivalent. The primary benefit of the proposed rule is
to provide credible assurance that the rapidly increasing volume of EC
Member States' imports into the United States meet pharmaceutical GMP
requirements, and medical device quality system evaluation and certain
premarket evaluation requirements, as specified in U.S. statutes and
regulations. In the future, this credible assurance must be achievable
without resource expenditures by FDA that are directly proportional to
the volume of trade.
In recent years, the credibility of the current approach has been
strained as FDA's essentially constant foreign inspection capacity has
been stretched over an expanding volume of imports from the EC. In the
3-year interval between 1994 and 1997, the value of EC pharmaceutical
and medical device imports into the United States has nearly doubled
from $5.5 billion to more than $10.7 billion. Growth has been greatest
in pharmaceuticals, where
[[Page 17746]]
annual EC exports have increased by more than $2 billion in each of the
last 2 years. In 1997, FDA conducted one inspection in the EC for every
$60 million in pharmaceutical exports to the United States, which is
less than half the coverage intensity of 1994. In addition, the
majority of these inspections have been preapproval in nature.
Continuation of the current trend will further decrease FDA's coverage
intensity to less than one inspection per $100 million in EC
pharmaceutical exports by the year 2000. Equivalence with EC Member
State regulatory systems has the potential for leveraging FDA's
regulatory resources so that necessary conformity assessments can be
ensured for higher volumes of future trade.
In addition to coping with higher trade volumes, mutual recognition
or equivalence-based agreements with exporting nations may permit FDA
to redirect some of its inspectional resources to risk priorities not
covered by such agreements. This flexibility would provide a more
responsive level of U.S. consumer protection in the face of a changing
global marketplace with inherently variable risk management priorities.
Another important benefit of the proposed rule would be the cost
savings realized by the regulated industry, largely as a result of
sharing inspection reports among equivalent regulatory authorities.
This exchange, in turn, will eliminate the need for duplicative
inspections and permit individual firms to undergo fewer inspections of
manufacturing sites. FDA does not have data on the average
administrative cost incurred by pharmaceutical (including biological)
or medical device manufacturers as they participate in regulatory
inspections, but it is reasonable to assume that the avoidance of
redundant inspections would generate cost savings. The proposed rule
also may shorten product review times for regulated products as a
result of the increased efficiency of premarket approval inspection
activities and the third-party evaluation of certain medical devices.
Quantification of this savings will be highly dependent on the specific
countries that achieve equivalence and the number of medical device
audits and evaluations performed by conformity assessment bodies.
The costs of this regulation appear to impact more directly on
governmental regulatory agencies than on the regulated industry. These
governmental costs involve both startup and operational components. FDA
has not received additional government funding earmarked for achieving
mutual recognition agreements. FDA, therefore, must proceed to
implement these agreements as a concurrent function within normal day-
to-day regulatory activities. The 3-year transition period reflects the
necessity to absorb these startup costs within existing regulatory
budgets. Some activities such as joint inspections may be reasonably
easy to absorb as concurrent functions that do not require additional
funding, while others such as developing and maintaining systems for
routine information exchange may involve new activities. These absorbed
governmental costs will fall heavily on FDA, as it must assess
equivalence of multiple EC Member States and notified bodies.
For FDA, the absorption of these startup costs will be easier with
respect to those EC Member States with a large volume of trade, where
FDA already conducts enough inspections to gather a general
understanding of the requirements and regulatory practices of the
exporting country. From this perspective, the pace and priorities for
mutual recognition agreements during the transition period may be
dictated by FDA's ability to conduct these processes as concurrent
functions within current activities.
In the longer run, an operational system of mutual recognition
agreements could pose additional costs on regulatory authorities of
exporting countries if equivalence requires a frequency, focus or
content of inspections not presently included in regulatory
requirements of the exporting nation. For example, Country A may not be
able to provide the frequency of medical device inspections desired by
Country B without conducting inspections beyond those required for
Country A's domestic inspection strategy. Conversely, Country B may not
be able to provide to Country A adequate details of the quality of
pharmaceutical source materials, because Country B does not have
inspectional authority over pharmaceutical starting materials. To the
extent such costs are insignificant or offset by other savings, they
will not likely be obstacles to reaching agreement on equivalence.
This proposal is not expected to involve any new incremental costs
to the affected industry. Although joint inspections during the
transition period may create the appearance of more regulatory effort,
they should not impose additional costs on the firms inspected. FDA
does not anticipate an increase in the total number of inspections, and
in fact, the coverage intensity of FDA inspections in the EC would
continue to fall during the transition period, as it has been for the
past several years. Other activities related to equivalence
determinations, such as the procedures for exchanging information and
reports, focus on the interface and coordination between regulatory
agencies and, as such, do not affect industry in a cost context.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities unless the rule is not expected to have a significant
impact on a substantial number of small entities. As the proposed
regulation is not expected to impose costs on the regulated industry,
the agency certifies that the proposed rule would not have a
significant impact on a substantial number of small entities.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required.
The Unfunded Mandates Act of 1995 requires that agencies prepare an
assessment of the anticipated costs and benefits before issuing any
final rule that may result in expenditures by State, local, and tribal
governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one year.
This proposed rule does not impose any mandates on State, local or
tribal governments, or the private sector that would result in an
annual expenditure of $100,000,000 or more. Therefore, no further
analysis is appropriate for this requirement.
V. Paperwork Reduction Act of 1995
This proposed rule does not contain any information collection
provisions that would be subject to review by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520).
VI. Request for Comments
Interested persons may, on or before May 11, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this proposed regulation. Comments must be received by the Dockets
Management Branch by 4:30 p.m. Eastern Standard Time May 11, 1998. Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments are to be identified with the docket number
found in brackets in the heading of this document. Received comments, a
copy of the MRA, and a summary explanation of the MRA's provisions, to
aid in commenting, may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday. In addition, an electronic copy of the MRA
and the summary
[[Page 17747]]
explanation is available on FDA's web site at ``http://www.fda.gov''
under the ``international'' heading menu item.
The comment period in this document is shorter than the 60 days FDA
customarily provides for proposed rules (21 CFR 10.40(b)(2)). FDA
believes it is unnecessary to provide 60 days for comment, given the
opportunities for public comment the agency already has provided.
During the course of the negotiations of the MRA, FDA provided a number
of opportunities for public discussion. For example, on May 9, 1996 (61
FR 21194), FDA established a public docket for information concerning
the MRA (Ref. 6). In addition, on October 18, 1996, FDA made available
for public comment copies of a document entitled, ``FDA Proposal for an
Agreement With the European Union Concerning the Mutual Recognition of
Inspections to Determine Adherence to Manufacturing Practices for
Pharmaceuticals Including Biologicals.'' FDA formally sought public
comment on this proposal through a Federal Register notice (61 FR
54448, October 18, 1996). To provide opportunity for public input into
the pharmaceutical GMP discussions with the European Commission, FDA
hosted public exchange meetings in Washington, DC, and Rockville, MD,
on March 31, 1995 (see 60 FR 15934, March 28, 1995), and October 30,
1996 (see 61 FR 54448, October 18, 1996). On November 8 and 9, 1996, a
transatlantic business dialogue (TABD) meeting included an extensive
discussion of the unresolved issues for the pharmaceutical and medical
device annexes to the MRA (Ref. 7), and on March 14, 1997, FDA
participated in a meeting of U.S. agencies and nongovernmental
organizations, which included several consumer, industry, and
environmental groups. Finally, FDA provided information and solicited
comment on the MRA at a September 23, 1997, National Consumer Forum
held in Washington, DC. The purpose of the forum was to facilitate
dialogue on the MRA between FDA and consumers.
In light of the extensive opportunities for public participation,
FDA believes there is good cause to provide 30 days for comment on this
proposed rule. The agency also believes it is in the public interest to
proceed expeditiously to implement the MRA, so that it can proceed
toward the anticipated resource efficiencies and enhancement of product
safety, effectiveness, and quality that the MRA can provide. The 30-day
comment period provides sufficient opportunity to receive and consider
comments before the anticipated signing of the MRA in late spring or
early summer.
The agency also notes that the comment period is less than that
required by Executive Order 12889 (58 FR 69681, December 30, 1993).
Section 4 of Executive Order 12889 states that any agency subject to
the Administrative Procedure Act shall provide a 75-day comment period
for any proposed technical regulation. Because this proposed rule
creates no new technical obligations or mandatory requirements on the
public, FDA believes that it is not a technical regulation subject to
Section 4 of Executive Order 12889. As a result, a 75-day comment
period is not required for this proposed rule.
VII. References
1. The European Community consists of the following member
States: Austria, Belgium, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Luxembourg, The Netherlands, Portugal, Spain,
Sweden, and the United Kingdom. These countries have vested in the
European Commission the authority to conduct certain international
negotiations, on their behalf, with other countries such as the
United States.
2. On June 20, 1997, U.S. Trade Representative Charlene
Barshefsky and European Commission Vice President Leon Brittan
signed ``Agreed Minutes on the Agreement on Mutual Recognition
between the United States of America and the European Community,''
which states that the MRA ``represents the text we commit to submit
to our respective authorities with a view to completing the
necessary procedures for approval and implementation.'' The complete
text of the MRA is available on the Internet at FDA's web site,
``http://www.fda.gov'', under the ``international'' menu item or on
the European Community web site, ``http://europa.eu.int/en/comm/
dg01/mra03.htm''.
3. Food and Drug Administration Modernization Act of 1997
(FDAMA), section 417, Pub. L. 105-115, 111 Stat. 2296 (1997) (to be
codified at 21 U.S.C. 360(i)(3)).
4. Provisions in the act that govern FDA regulation of
pharmaceuticals and medical devices include sections 501, 502, 505,
512, 513, 520, and 522 (21 U.S.C. 351, 352, 355, 360b, 360c, 360j,
and 360l).
5. FDAMA section 410 (to be codified at 21 U.S.C. 383(c)(2)).
6. Information in the docket includes summaries of minutes of
the meetings described in this document with written comments
received from interested parties, summaries of the various
negotiation sessions between FDA and the European Commission and EC
Member State representatives, and copies of draft agreements
covering pharmaceutical GMP's and medical devices that were
exchanged between the EC and FDA in December 1996 and January 1997.
7. The TABD is an industry-driven initiative that aims to
facilitate closer economic relations between the EC and the United
States.
VIII. Comparison Table
The following table shows the relationship of the MRA Articles and
the sections of the Code of Federal Regulations (CFR) as proposed under
this rule:
Table 1.--Relationship of the MRA Articles to sections in the CFR
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MRA Article CFR Section
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Sectoral Annex for Pharmaceutical GMP's Subpart A
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Article 1................................. 26.1
Article 2................................. 26.2
Article 3................................. 26.3
Article 4................................. 26.4
Article 5................................. 26.5
Article 6................................. 26.6
Article 7................................. 26.7
Article 8................................. 26.8
Article 9................................. 26.9
Article 10................................ 26.10
Article 11................................ 26.11
Article 12................................ 26.12
Article 13................................ 26.13
Article 14................................ 26.14
Article 15................................ 26.15
Article 16................................ 26.16
Article 17................................ 26.17
Article 18................................ 26.18
Article 19................................ 26.19
Article 20................................ 26.20
Article 21................................ 26.21
Appendix 1................................ Appendix A
Appendix 2................................ Appendix B
Appendix 3................................ Appendix C
Appendix 4................................ Appendix D
Appendix 5................................ Appendix E
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MRA Article CFR Section
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Sectoral Annex on Medical Devices Subpart B
------------------------------------------------------------------------
Article 1................................. 26.31
Article 2................................. 26.32
Article 3................................. 26.33
Article 4................................. 26.34
Article 5................................. 26.35
Article 6................................. 26.36
Article 7................................. 26.37
Article 8................................. 26.38
Article 9................................. 26.39
Article 10................................ 26.40
Article 11................................ 26.41
Article 12................................ 26.42
Article 13................................ 26.43
Article 14................................ 26.44
Article 15................................ 26.45
Article 16................................ 26.46
Article 17................................ 26.47
Article 18................................ 26.48
Article 19................................ 26.49
Article 20................................ 26.50
Appendix 1................................ Appendix A
[[Page 17748]]
Appendix 2 and Tables 1-3................. Appendix B and Tables 1-3
Appendix 3 [Reserved]..................... Appendix C [Reserved]
Appendix 4 [Reserved]..................... Appendix D [Reserved]
Appendix 5 [Reserved]..................... Appendix E [Reserved]
Appendix 6 [Reserved]..................... Appendix F [Reserved]
------------------------------------------------------------------------
------------------------------------------------------------------------
MRA Article CFR Section
------------------------------------------------------------------------
Umbrella Agreement Subpart C
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Article 1................................. 26.60
Article 2................................. 26.61
Article 3................................. 26.62
Article 4................................. 26.63
Article 5................................. 26.64
Article 6................................. 26.65
Article 7................................. 26.66
Article 8................................. 26.67
Article 9................................. 26.68
Article 10................................ 26.69
Article 11................................ 26.70
Article 12................................ 26.71
Article 13................................ 26.72
Article 14................................ 26.73
Article 15................................ 26.74
Article 16................................ 26.75
Article 17................................ 26.76
Article 18................................ 26.77
Article 19................................ 26.78
Article 20................................ 26.79
Article 21................................ 26.80
Article 22................................ 26.81
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List of Subjects in 21 CFR Part 26
Animal and human drugs, Biologicals, Devices, Exports, Imports,
Incorporation by reference, and Inspections.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be
amended by adding part 26 to read as follows:
PART 26--MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING
PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND
CERTAIN MEDICAL DEVICE PREMARKET EVALUATION REPORTS PROVIDED BY
EUROPEAN COMMUNITY MEMBER STATE REGULATORY AUTHORITIES AND EUROPEAN
COMMUNITY CONFORMITY ASSESSMENT BODIES
Sec.
26.0 General.
Subpart A--Specific Sector Provisions for Pharmaceutical Good
Manufacturing Practices
26.1 Definitions.
26.2 Purpose.
26.3 Scope.
26.4 Product coverage.
26.5 Length of transition period.
26.6 Equivalence assessment.
26.7 Participation in the equivalence assessment and determination.
26.8 Other transition activities.
26.9 Equivalence determination.
26.10 Regulatory authorities not listed as currently equivalent.
26.11 Start of operational period.
26.12 Nature of recognition of inspection reports.
26.13 Transmission of postapproval inspection reports.
26.14 Transmission of preapproval inspection reports.
26.15 Monitoring continued equivalence.
26.16 Suspension.
26.17 Role and composition of the Joint Sectoral Committee.
26.18 Regulatory collaboration.
26.19 Information relating to quality aspects.
26.20 Alert system.
26.21 Safeguard clause.
Appendix A of Subpart A--List of Applicable Laws, Regulations, and
Administrative provisions.
Appendix B of Subpart A--List of Authorities.
Appendix C of Subpart A--Indicative List of Products Covered by
Subpart A.
Appendix D of Subpart A--Criteria for Assessing Equivalence for
Post- and Preapproval.
Appendix E of Subpart A--Elements to be Considered in Developing a
Two-way Alert System.
Subpart B--Specific Sector Provisions for Medical Devices
26.31 Purpose.
26.32 Scope.
26.33 Product coverage.
26.34 Regulatory authorities.
26.35 Length and purpose of transition period.
26.36 Listing of CAB's.
26.37 Confidence building activities.
26.38 Other transition period activities.
26.39 Equivalence assessment.
26.40 Start of the operational period.
26.41 Exchange and endorsement of quality system evaluation reports.
26.42 Exchange and endorsement of product evaluation reports.
26.43 Transmission of quality system evaluation reports.
26.44 Transmission of product evaluation reports.
26.45 Monitoring continued equivalence.
26.46 Listing of additional CAB's.
26.47 Role and composition of the Joint Sectoral Committee.
26.48 Harmonization.
26.49 Regulatory cooperation.
26.50 Alert system and exchange of postmarket vigilance reports.
Appendix A of Subpart B--Relevant Legislation, Regulations and
Procedures
Appendix B of Subpart B--Scope of Product Coverage
Appendix C of Subpart B [Reserved]
Appendix D of Subpart B [Reserved]
Appendix E of Subpart B [Reserved]
Appendix F of Subpart B [Reserved]
Subpart C--Framework or ``Umbrella'' Provisions
26.60 Definitions.
26.61 Purpose of this part.
26.62 General obligations.
26.63 General coverage of this part.
26.64 Transitional arrangements.
26.65 Designating authorities.
26.66 Designation and listing procedures.
26.67 Suspension of listed conformity assessment bodies.
26.68 Withdrawal of listed conformity assessment bodies.
26.69 Monitoring of conformity assessment bodies.
26.70 Conformity assessment bodies.
26.71 Exchange of information.
26.72 Sectoral contact points.
26.73 Joint Committee.
26.74 Preservation of regulatory authority.
26.75 Suspension of recognition obligations.
26.76 Confidentiality.
26.77 Fees.
26.78 Agreements with other countries.
26.79 Territorial application.
26.80 Entry into force, amendment and termination.
26.81 Final provisions.
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 343, 351,
352, 355, 360, 360b, 360c, 360d, 360e, 360f, 360g, 360h, 360i, 360j,
360l, 371, 374, 381, 382, 383, 393; 42 U.S.C. 216, 241, 242l, 262,
264, 265.
Sec. 26.0 General.
This part substantially reflects relevant provisions of the
proposed international agreement entitled, ``Agreement on Mutual
Recognition Between the United States of America and the European
Community'' (the MRA), including the ``umbrella'' text and its sectoral
annexes on pharmaceutical good manufacturing practices (GMP's) and
medical devices. Whereas the parties to the MRA would be the United
States and the European Community (EC), this part is relevant only to
the Food and Drug Administration's (FDA's) implementation of the MRA
and the
[[Page 17749]]
sectoral annexes cited in this section. For codification purposes,
certain provisions of the MRA have been modified for use in this part.
This modification is done for purposes of clarity only and shall not
affect the text of the MRA to be concluded between the United States
and the EC, or the rights and obligations of the United States or EC
under that agreement. References to the terms ``party'' or ``parties''
reflect FDA's proposed implementation of the MRA and its sectoral
annexes. It is understood that the EC will also be a party to the MRA
and that it will implement the MRA in accordance with its internal
procedures. If the parties to the MRA subsequently amend or terminate
the MRA, FDA will modify this part accordingly, using appropriate
administrative procedures.
Subpart A--Specific Sector Provisions for Pharmaceutical Good
Manufacturing Practices
Sec. 26.1 Definitions.
(a) Enforcement means action taken by an authority to protect the
public from products of suspect quality, safety, and efficacy or to
assure that products are manufactured in compliance with appropriate
laws, regulations, standards, and commitments made as part of the
approval to market a product.
(b) Equivalence of the regulatory systems means that the systems
are sufficiently comparable to assure that the process of inspection
and the ensuing inspection reports will provide adequate information to
determine whether respective statutory and regulatory requirements of
the authorities have been fulfilled. Equivalence does not require that
the respective regulatory systems have identical procedures.
(c) Good Manufacturing Practices (GMP's): [These GMP conceptual
definitions are to be merged by the parties at a future date.]
(1) GMP's mean the requirements found in the respective
legislations, regulations, and administrative provisions for methods to
be used in, and the facilities or controls to be used for, the
manufacturing, processing, packing, and/or holding of a drug to assure
that such drug meets the requirements as to safety, and has the
identity and strength, and meets the quality and purity characteristics
that it purports or is represented to possess.
(2) GMP's are that part of quality assurance which ensures that
products are consistently produced and controlled to quality standards.
For the purpose of this subpart, GMP's include, therefore, the system
whereby the manufacturer receives the specifications of the product
and/or process from the marketing authorization/product authorization
or license holder or applicant and ensures the product is made in
compliance with its specifications (qualified person certification in
the European Community (EC)).
(d) Inspection means an onsite evaluation of a manufacturing
facility to determine whether such manufacturing facility is operating
in compliance with GMP's and/or commitments made as part of the
approval to market a product.
(e) Inspection Report means the written observations and GMP's
compliance assessment completed by an authority listed in Appendix B of
this subpart.
(f) Regulatory System means the body of legal requirements for
GMP's, inspections, and enforcements that ensure public health
protection and legal authority to assure adherence to these
requirements.
Sec. 26.2 Purpose.
The provisions of this subpart govern the exchange between the
parties and normal endorsement by the receiving regulatory authority of
official good manufacturing practice (GMP) inspection reports after a
transitional period aimed at determination of the equivalence of the
regulatory systems of the parties, which is the cornerstone of this
subpart.
Sec. 26.3 Scope.
(a) The provisions of this subpart shall apply to pharmaceutical
inspections carried out in the United States and Member States of the
European Community (EC) before products are marketed (hereafter
referred to as ``preapproval inspections'') as well as during their
marketing (hereafter referred to as ``postapproval inspections'').
(b) Appendix A of this subpart names the laws, regulations, and
administrative provisions governing these inspections and the good
manufacturing practice (GMP) requirements.
(c) Appendix B of this subpart lists the authorities participating
in activities under this subpart.
(d) Sections 26.65, 26.66, 26.67, 26.68, 26.69, and 26.70 of
subpart C of this part do not apply to this subpart.
Sec. 26.4 Product coverage.
(a) These provisions will apply to medicinal products for human or
animal use, intermediates and starting materials (as referred to in the
European Community (EC)) and to drugs for human or animal use,
biological products for human use, and active pharmaceutical
ingredients (as referred to in the United States), only to the extent
they are regulated by the authorities of both parties as listed in
Appendix B of this subpart.
(b) Human blood, human plasma, human tissues and organs, and
veterinary immunologicals (under 9 CFR 101.2, ``veterinary
immunologicals'' are referred to as ``veterinary biologicals'') are
excluded from the scope of this subpart. Human plasma derivatives (such
as immunoglobulins and albumin), investigational medicinal products/new
drugs, human radiopharmaceuticals, and medicinal gases are also
excluded during the transition phase, their situation will be
reconsidered at the end of the transition period. Products regulated by
FDA's Center for Biologics Evaluation and Research as devices are not
covered under this subpart.
(c) Appendix C of this subpart contains an indicative list of
products covered by this subpart.
Sec. 26.5 Length of transition period.
A 3-year transition period will start immediately after the
effective date described in Sec. 26.80(a).
Sec. 26.6 Equivalence assessment.
(a) The criteria to be used by the parties to assess equivalence
are listed in Appendix D of this subpart. Information pertaining to the
criteria under European Community (EC) competence will be provided by
the EC.
(b) The authorities of the parties will establish and communicate
to each other their draft programs for assessing the equivalence of the
respective regulatory systems in terms of quality assurance of the
products and consumer protection. These programs will be carried out,
as deemed necessary by the regulatory authorities, for post- and
preapproval inspections and for various product classes or processes.
(c) The equivalence assessment shall include information exchanges
(including inspection reports), joint training, and joint inspections
for the purpose of assessing regulatory systems and the authorities'
capabilities. In conducting the equivalence assessment, the parties
will ensure that efforts are made to save resources.
(d) Equivalence assessment for authorities added to Appendix B of
this subpart after the effective date of this part as described in
Sec. 26.80(a) will be conducted as described in this subpart, as soon
as practicable.
[[Page 17750]]
Sec. 26.7 Participation in the equivalence assessment and
determination.
The authorities listed in Appendix B of this subpart will actively
participate in these programs to build a sufficient body of evidence
for their equivalence determination. Both parties will exercise good
faith efforts to complete equivalence assessment as expeditiously as
possible to the extent the resources of the authorities allow.
Sec. 26.8 Other transition activities.
As soon as possible, the authorities will jointly determine the
essential information which must be present in inspection reports and
will cooperate to develop mutually agreed inspection report format(s).
Sec. 26.9 Equivalence determination.
(a) Equivalence is established by having in place regulatory
systems covering the criteria referred to in Appendix D of this
subpart, and a demonstrated pattern of consistent performance in
accordance with these criteria. A list of authorities determined as
equivalent shall be agreed to by the Joint Sectoral Committee at the
end of the transition period, with reference to any limitation in terms
of inspection type (e.g., postapproval or preapproval) or product
classes or processes.
(b) The parties will document insufficient evidence of equivalence,
lack of opportunity to assess equivalence or a determination of
nonequivalence, in sufficient detail to allow the authority being
assessed to know how to attain equivalence.
Sec. 26.10 Regulatory authorities not listed as currently equivalent.
Authorities not currently listed as equivalent, or not equivalent
for certain types of inspections, product classes or processes may
apply for reconsideration of their status once the necessary corrective
measures have been taken or additional experience is gained.
Sec. 26.11 Start of operational period.
(a) The operational period shall start at the end of the transition
period and its provisions apply to inspection reports generated by
authorities listed as equivalent for the inspections performed in their
territory.
(b) In addition, when an authority is not listed as equivalent
based on adequate experience gained during the transition period, FDA
will accept for normal endorsement (as provided in Sec. 26.12)
inspection reports generated as a result of inspections conducted
jointly by that authority on its territory and another authority listed
as equivalent, provided that the authority of the Member State in which
the inspection is performed can guarantee enforcement of the findings
of the inspection report and require that corrective measures be taken
when necessary. FDA has the option to participate in these inspections,
and based on experience gained during the transition period, the
parties will agree on procedures for exercising this option.
(c) In the European Community (EC), the qualified person will be
relieved of responsibility for carrying the controls laid down in
Article 22 paragraph 1(b) of Council Directive 75/319/EEC (see Appendix
A of this subpart) provided that these controls have been carried out
in the United States and that each batch/lot is accompanied by a batch
certificate (in accordance with the World Health Organization
Certification Scheme on the Quality of Medicinal Products) issued by
the manufacturer certifying that the product complies with requirements
of the marketing authorization and signed by the person responsible for
releasing the batch/lot.
Sec. 26.12 Nature of recognition of inspection reports.
(a) Inspection reports (containing information as established under
Sec. 26.8), including a good manufacturing practice (GMP) compliance
assessment, prepared by authorities listed as equivalent, will be
provided to the authority of the importing party. Based on the
determination of equivalence in light of the experience gained, these
inspection reports will normally be endorsed by the authority of the
importing party, except under specific and delineated circumstances.
Examples of such circumstances include indications of material
inconsistencies or inadequacies in an inspection report, quality
defects identified in the postmarket surveillance or other specific
evidence of serious concern in relation to product quality or consumer
safety. In such cases, the authority of the importing party may request
clarification from the authority of the exporting party which may lead
to a request for reinspection. The authorities will endeavor to respond
to requests for clarification in a timely manner.
(b) Where divergence is not clarified in this process, an authority
of the importing country may carry out an inspection of the production
facility.
Sec. 26.13 Transmission of postapproval inspection reports.
Postapproval good manufacturing practice (GMP) inspection reports
concerning products covered by this subpart will be transmitted to the
authority of the importing country within 60 calendar days of the
request. Should a new inspection be needed, the inspection report will
be transmitted within 90 calendar days of the request.
Sec. 26.14 Transmission of preapproval inspection reports.
(a) A preliminary notification that an inspection may have to take
place will be made as soon as possible.
(b) Within 15 calendar days, the relevant authority will
acknowledge receipt of the request and confirm its ability to carry out
the inspection. In the European Community (EC), requests will be sent
directly to the relevant authority, with a copy to the European Agency
for the Evaluation of Medicinal Products (EMEA). If the authority
receiving the request cannot carry out the inspection as requested, the
requesting authority shall have the right to conduct the inspection.
(c) Reports of preapproval inspections will be sent within 45
calendar days of the request that transmitted the appropriate
information and detailed the precise issues to be addressed during the
inspection. A shorter time may be necessary in exceptional cases and
these will be described in the request.
Sec. 26.15 Monitoring continued equivalence.
Monitoring activities for the purpose of maintaining equivalence
shall include review of the exchange of inspection reports and their
quality and timeliness; performance of a limited number of joint
inspections; and the conduct of common training sessions.
Sec. 26.16 Suspension.
(a) Each party has the right to contest the equivalence of a
regulatory authority. This right will be exercised in an objective and
reasoned manner in writing to the other party.
(b) The issue shall be discussed in the Joint Sectoral Committee
promptly upon such notification. Where the Joint Sectoral Committee
determines that verification of equivalence is required, it may be
carried out jointly by the parties in a timely manner, under Sec. 26.6.
(c) Efforts will be made by the Joint Sectoral Committee to reach
unanimous consent on the appropriate action. If agreement to suspend is
reached in the Joint Sectoral Committee, an authority may be suspended
immediately thereafter. If no agreement is reached in the Joint
Sectoral Committee, the matter is referred to the Joint Committee as
described in Sec. 26.73. If no unanimous consent is reached within 30
days after such notification, the contested authority will be
suspended.
(d) Upon the suspension of authority previously listed as
equivalent, a party
[[Page 17751]]
is no longer obligated to normally endorse the inspection reports of
the suspended authority. A party shall continue to normally endorse the
inspection reports of that authority prior to suspension, unless the
authority of the receiving party decides otherwise based on health or
safety considerations. The suspension will remain in effect until
unanimous consent has been reached by the parties on the future status
of that authority.
Sec. 26.17 Role and composition of the Joint Sectoral Committee.
(a) A Joint Sectoral Committee is set up to monitor the activities
under both the transitional and operational phases of this subpart.
(b) The Joint Sectoral Committee will be cochaired by a
representative of FDA for the United States and a representative of the
European Community (EC) who each will have one vote. Decisions will be
taken by unanimous consent.
(c) The Joint Sectoral Committee's functions will include:
(1) Making a joint assessment, which must be agreed by both
parties, of the equivalence of the respective authorities;
(2) Developing and maintaining the list of equivalent authorities,
including any limitation in terms of inspecting type or products, and
communicating the list to all authorities and the Joint Committee;
(3) Providing a forum to discuss issues relating to this subpart,
including concerns that an authority may be no longer equivalent and
opportunity to review product coverage; and
(4) Consideration of the issue of suspension.
(d) The Joint Sectoral Committee shall meet at the request of
either party and, unless the cochairs otherwise agree, at least once
each year. The Joint Committee will be kept informed of the agenda and
conclusions of meetings of the Joint Sectoral Committee.
Sec. 26.18 Regulatory collaboration.
(a) The parties and authorities shall inform and consult one
another, as permitted by law, on proposals to introduce new controls or
to change existing technical regulations or inspection procedures and
to provide the opportunity to comment on such proposals.
(b) The parties shall notify each other in writing of any changes
to Appendix B of this subpart.
Sec. 26.19 Information relating to quality aspects.
The authorities will establish an appropriate means of exchanging
information on any confirmed problem reports, corrective actions,
recalls, rejected import consignments and other regulatory and
enforcement problems for products subject to this subpart.
Sec. 26.20 Alert system.
(a) The details of an alert system will be developed during the
transitional period. The system will be maintained in place at all
times. Elements to be considered in developing such a system are
described in Appendix E of this subpart.
(b) Contact points will be agreed between both parties to permit
authorities to be made aware with the appropriate speed in case of
quality defect, recalls, counterfeiting, and other problems concerning
quality, which could necessitate additional controls or suspension of
the distribution of the product.
Sec. 26.21 Safeguard clause.
Each party recognizes that the importing country has a right to
fulfill its legal responsibilities by taking actions necessary to
ensure the protection of human and animal health at the level of
protection it deems appropriate. This includes the suspension of the
distribution, product detention at the border of the importing country,
withdrawal of the batches and any request for additional information or
inspection as provided in Sec. 26.12.
Appendix A of Subpart A--List of Applicable Laws, Regulations, and
Administrative Provisions
1. For the European Community:
[Copies of EC documents may be obtained from the European
Document Research, 1100 17th St. NW., suite 301, Washington, DC
20036. EC documents may be viewed on the European Commission
Pharmaceuticals Units web site at ``http://dg3.eudra.org.'']
Council Directive 65/65/EEC of 26 January 1965 on the approximation
of provisions laid down by law, regulation, or administrative action
relating to proprietary medicinal products as extended, widened, and
amended.
Council Directive 75/319/EEC of 20 May 1975 on the approximation of
provisions laid down by law, regulation or administrative action
relating to proprietary medicinal products as extended, widened and
amended.
Council Directive 81/851/EEC of 6 November 1981 on the approximation
of the laws of the Member States relating to veterinary medicinal
products as widened and amended.
Commission Directive 91/356/EEC of 13 June 1991 laying down the
principles and guidelines of good manufacturing practice for
medicinal products for human use.
Commission Directive 91/412/EEC of 23 July 1991 laying down the
principles and guidelines of good manufacturing practice for
veterinary medicinal products.
Council Regulation No (EEC) 2309/93 of 23 July 1993 laying down
Community procedures for the authorization and supervision of
medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products.
Council Directive 92/25/EEC of 31 March 1992 on the wholesale
distribution of medicinal products for human use & Guide to Good
Distribution Practice.
Current version of the Guide to Good Manufacturing Practice, Rules
Governing Medicinal Products in the European Community, Volume IV.
2. For the United States :
[Copies of FDA documents may be obtained from the Government
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA
documents, except the FDA Compliance Program Guidance Manual, may be
viewed on FDA's Internet web site at ``http://www.FDA.gov''.]
Relevant sections of the United States Federal Food, Drug, and
Cosmetic Act and the United States Public Health Service Act.
Relevant sections of Title 21, United States Code of Federal
Regulations (CFR) Parts 1-99, Parts 200-299, Parts 500-599, and
Parts 600-799.
Relevant sections of the FDA Investigations Operations Manual, the
FDA Regulatory Procedures Manual, the FDA Compliance Policy Guidance
Manual, the FDA Compliance Program Guidance Manual, and other FDA
guidances.
Appendix B of Subpart A--List of Authorities
1. For the United States:
In the United States, the regulatory authority is the Food and Drug
Administration.
2. For the European Community:
In the European Community, the regulatory authorities are the
following :
Austria: Bundesministerium Fur Arbeit, Gesundheit, und Soziales,
Wien.
Belgium: Ministerie van Sociale Zakem, Volksgezondheid en Leefmilieu
/Ministere des Affaires Sociales, Sante Publique et Environment/
Algemeine Farmaceutische Inspectie, Inspection Generale de la
Pharmacie, Bruxelles, Brussel.
Denmark: Laegemiddelstryelsen, (Danish Medicines Agency), Bronshoj.
Finland: Laakelaittos/Lakemedelsverket (National Agency for
Medicines), Helsinki.
France: Agence du Medicament, Direction de l'inspection et des
etablissements, Saint Denis. (Human). Agence Nationale du Medicament
Veterinaire, Fougeres (Veterinary).
Germany: Bundesgesundheitsministerium, Bonn. Paul-Ehrlich Institut,
Langen (biologicals only). Zustandige Behorden der 16 Bundeslander:
Bayern, Berlin Brandenberg, Bremen, Hamburg, Hessen, Niedersachsen,
Nordrhein-Westfalen, Rheinland-Pfalz, Mecklenberg-Vorpommern,
Saarland, Sachsen, Sachsenanhalt, Schleswog-Holstein, Thuringen.
Greece: Ministry of Health and Welfare, National Drug Organisation
(E.O.F.), Athens.
Ireland: Irish Medicines Board, Dublin.
[[Page 17752]]
Italy: Ministero della Sanita, Dipartimento Farmaci e
Farmacovigilanza, Roma. (Human). Ministero della Sanita,
Dipartimento alimenti e nutrizione e sanita pubblica veterinaria -
Div. IX, Roma (Veterinary).
Luxembourg: Direction de la Sante, Division de la Pharmacie et des
Medicaments, Luxembourg.
The Netherlands: Staatstoezicht op de Volksgezondheid, Inspectie
voor de Gezondheidszorg, Rijswijk.
Portugal: Instituto da Farmacia e do Medicamento (INFARMED), Lisboa.
Spain: Ministerio Sanidad y Consumo, Subdireccion. General de
Control Farmaceutico, Madrid. (Human) Ministerio de Agricultura
Pesca y Alimentacion, Madrid, (Veterinary).
Sweden: Lakemedelsverket (Medical Products Agency), Uppsala.
United Kingdom: Medicines Control Agency, London. Veterinary
Medicines Directorate, Addlestone.
European Union: European Commission, Brussels. European Agency for
the Evaluation of Medicinal Products (EMEA), London.
Appendix C of Subpart A--Indicative List of Products Covered by Subpart
A
Recognizing that precise definition of medicinal products and drugs
are to be found in the legislations referred to above, an indicative
list of products covered by this arrangement is given below:
- human medicinal products including prescription and
nonprescription drugs;
- human biologicals including vaccines, and immunologicals;
- veterinary pharmaceuticals, including prescription and
nonprescription drugs, with the exclusion of veterinary
immunologicals (Under 9 CFR 101.2 ``veterinary immunologicals'' are
referred to as ``veterinary biologicals.'');
- premixes for the preparation of veterinary medicated feeds
(EC), Type A medicated articles for the preparation of veterinary
medicated feeds (United States);
- intermediate products and active pharmaceutical ingredients or
bulk pharmaceuticals (United States)/starting materials (EC).
Appendix D of Subpart A--Criteria for Assessing Equivalence for Post-
and Preapproval
I. Legal/Regulatory authority and structures and procedures providing
for post- and preapproval:
A. Appropriate statutory mandate and jurisdiction.
B. Ability to issue and update binding requirements on GMP's and
guidance documents.
C. Authority to make inspections, review and copy documents, and to
take samples and collect other evidence.
D. Ability to enforce requirements and to remove products found in
violation of such requirements from the market.
E. Substantive current good manufacturing requirements.
F. Accountability of the regulatory authority.
G. Inventory of current products and manufacturers.
H. System for maintaining or accessing inspection reports, samples
and other analytical data, and other firm/product information
relating to matters covered by subpart A of this part.
II. Mechanisms in place to assure appropriate professional standards
and avoidance of conflicts of interest.
III. Administration of the regulatory authority:
A. Standards of education/qualification and training.
B. Effective quality assurance systems measures to ensure adequate
job performance.
C. Appropriate staffing and resources to enforce laws and
regulations.
IV. Conduct of inspections:
A. Adequate preinspection preparation, including appropriate
expertise of investigator/team, review of firm/product and
databases, and availability of appropriate inspection equipment.
B. Adequate conduct of inspection, including statutory access to
facilities, effective response to refusals, depth and competence of
evaluation of operations, systems, and documentation; collection of
evidence; appropriate duration of inspection and completeness of
written report of observations to firm management.
C. Adequate postinspection activities, including completeness of
inspectors' report, inspection report review where appropriate, and
conduct of followup inspections and other activities where
appropriate, assurance of preservation and retrieval of records.
V. Execution of regulatory enforcement actions to achieve corrections,
designed to prevent future violations, and to remove products found in
violation of requirements from the market.
VI. Effective use of surveillance systems:
A. Sampling and analysis.
B. Recall monitoring.
C. Product defect reporting system.
D. Routine surveillance inspections.
E. Verification of approved manufacturing process changes to
marketing authorizations/approved applications.
VII. Additional specific criteria for preapproval inspections:
A. Satisfactory demonstration through a jointly developed and
administered training program and joint inspections to assess the
regulatory authorities' capabilities.
B. Preinspection preparation includes the review of appropriate
records, including site plans and drug master file or similar
documentation to enable adequate inspections.
C. Ability to verify chemistry, manufacturing, and control data
supporting an application is authentic and complete.
D. Ability to assess and evaluate research and development data as
scientifically sound, especially transfer technology of pilot, scale
up and full scale production batches.
E. Ability to verify conformity of the onsite processes and
procedures with those described in the application.
F. Review and evaluate equipment installation, operational and
performance qualification data, and evaluate test method validation.
Appendix E of Subpart A--Elements to be Considered in Developing a Two-
way Alert System
1. Documentation
- Definition of a crisis/emergency and under what circumstances an
alert is required
- Standard Operating Procedures (SOP's)
- Mechanism of health hazards evaluation and classification
- Language of communication and transmission of information
2. Crisis Management System
- Crisis analysis and communication mechanisms
- Establishment of contact points
- Reporting mechanisms
3. Enforcement Procedures
- Followup mechanisms
- Corrective action procedures
4. Quality Assurance System
- Pharmacovigilance programme
- Surveillance/monitoring of implementation of corrective action
5. Contact Points
For the purpose of subpart A of this part, the contact points for
the alert system will be:
A. For the European Community:
the Executive Director of the European Agency for the Evaluation of
Medicinal Products, 7, Westferry Circus, Canary Wharf, UK - London
E14 4HB, England. Telephone 44-171-418 8400, Fax 418 8416.
B. For the United States :
Division of Emergency and Investigational Operations (DEIO), Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Telephone 301-443-1240, Fax 301-443-3757.
Subpart B--Specific Sector Provisions for Medical Devices
Sec. 26.31 Purpose.
(a) The purpose of this subpart is to specify the conditions under
which a party will accept the results of quality system-related
evaluations and inspections and premarket evaluations of the other
party with regard to medical devices as conducted by listed conformity
assessment bodies (CAB's) and to provide for other related cooperative
activities.
(b) This subpart is intended to evolve as programs and policies of
the parties evolve. The parties will review this subpart periodically,
in order to assess progress and identify potential enhancements to this
subpart as FDA and European Community (EC) policies evolve over time.
Sec. 26.32 Scope.
(a) The provisions of this subpart shall apply to the exchange and,
where appropriate, endorsement of the following types of reports from
conformity assessment bodies (CAB's) assessed to be equivalent:
[[Page 17753]]
(1) Under the U.S. system, surveillance/postmarket and initial/
preapproval inspection reports;
(2) Under the U.S. system, premarket (510(k)) product evaluation
reports;
(3) Under the European Community (EC) system, quality system
evaluation reports; and
(4) Under the EC system, EC type examination and verification
reports.
(b) Appendix A of this subpart names the legislation, regulations,
and related procedures under which:
(1) Products are regulated as medical devices by each party;
(2) CAB's are designated and confirmed; and
(3) These reports are prepared.
(c) For purposes of this subpart, equivalence means that: CAB's in
the EC are capable of conducting product and quality systems
evaluations against U.S. regulatory requirements in a manner equivalent
to those conducted by FDA; and CAB's in the United States are capable
of conducting product and quality systems evaluations against EC
regulatory requirements in a manner equivalent to those conducted by EC
CAB's.
Sec. 26.33 Product coverage.
(a) There are three components to this subpart each covering a
discrete range of products:
(1) Quality System Evaluations. U.S.-type surveillance/postmarket
and initial/preapproval inspection reports and European Community (EC)-
type quality system evaluation reports will be exchanged with regard to
all products regulated under both U.S. and EC law as medical devices.
(2) Product Evaluation. U.S.-type premarket (510(k)) product
evaluation reports and EC-type-testing reports will be exchanged only
with regard to those products classified under the U.S. system as Class
I/Class II-Tier 2 medical devices which are listed in Appendix B of
this subpart.
(3) Postmarket Vigilance Reports. Postmarket vigilance reports will
be exchanged with regard to all products regulated under both U.S. and
EC law as medical devices.
(b) Additional products and procedures may be made subject to this
subpart by agreement of the parties.
Sec. 26.34 Regulatory authorities.
The regulatory authorities shall have the responsibility of
implementing the provisions of this subpart, including the designation
and monitoring of conformity assessment bodies (CAB's). Regulatory
authorities will be specified in Appendix C of this subpart.. Each
party will promptly notify the other party in writing of any change in
the regulatory authority for a country.
Sec. 26.35 Length and purpose of transition period.
There will be a 3-year transition period immediately following the
date described in Sec. 26.80(a). During the transition period, the
parties will engage in confidence-building activities for the purpose
of obtaining sufficient evidence to make determinations concerning the
equivalence of conformity assessment bodies (CAB's) of the other party
with respect to the ability to perform quality system and product
evaluations or other reviews resulting in reports to be exchanged under
this subpart.
Sec. 26.36 Listing of CAB's.
Each party shall designate conformity assessment bodies (CAB's) to
participate in confidence-building activities by transmitting to the
other party a list of CAB's which meet the criteria for technical
competence and independence, as identified in Appendix A of this
subpart. The list shall be accompanied by supporting evidence.
Designated CAB's will be listed in Appendix D of this subpart for
participation in the confidence building activities once confirmed by
the importing party. Nonconfirmation would have to be justified based
on documented evidence.
Sec. 26.37 Confidence building activities.
(a) At the beginning of the transitional period, the Joint Sectoral
Group will establish a joint confidence building program calculated to
provide sufficient evidence of the capabilities of the designated
conformity assessment bodies (CAB's) to perform quality system or
product evaluations to the specifications of the parties.
(b) The joint confidence building program should include the
following actions and activities:
(1) Seminars designed to inform the parties and CAB's about each
party's regulatory system, procedures, and requirements;
(2) Workshops designed to provide the parties with information
regarding requirements and procedures for the designation and
surveillance of CAB's;
(3) Exchange of information about reports prepared during the
transition period;
(4) Joint training exercises; and
(5) Observed inspections.
(c) During the transition period, any significant problem that is
identified with a CAB may be the subject of cooperative activities, as
resources allow and as agreed to by the regulatory authorities, aimed
at resolving the problem.
(d) Both parties will exercise good faith efforts to complete the
confidence building activities as expeditiously as possible to the
extent that the resources of the parties allow.
(e) Both the parties will each prepare annual progress reports
which will describe the confidence building activities undertaken
during each year of the transition period. The form and content of the
reports will be determined by the parties through the Joint Sectoral
Committee.
Sec. 26.38 Other transition period activities.
(a) During the transition period, the parties will jointly
determine the necessary information which must be present in quality
system and product evaluation reports.
(b) The parties will jointly develop a notification and alert
system to be used in case of defects, recalls, and other problems
concerning product quality that could necessitate additional actions
(e.g., inspections by the parties of the importing country) or
suspension of the distribution of the product.
Sec. 26.39 Equivalence assessment.
(a) In the final 6 months of the transition period, the parties
shall proceed to a joint assessment of the equivalence of the
conformity assessment bodies (CAB's) that participated in the
confidence building activities. CAB's will be determined to be
equivalent provided they have demonstrated proficiency through the
submission of a sufficient number of adequate reports. CAB's may be
determined to be equivalent with regard to the ability to perform any
type of quality system or product evaluation covered by this subpart
and with regard to any type of product covered by this subpart. The
parties shall develop a list contained in Appendix E of this subpart of
CAB's determined to be equivalent which shall contain a full
explanation of the scope of the equivalency determination, including
any appropriate limitations, with regard to performing any type of
quality system or product evaluation.
(b) The parties shall allow CAB's not listed for participation in
this subpart, or listed for participation only as to certain types of
evaluations, to apply for participation in this subpart once the
necessary measures have been taken or sufficient experience has been
gained, in accordance with Sec. 26.46.
(c) Decisions concerning the equivalence of CAB's must be agreed to
by both parties.
[[Page 17754]]
Sec. 26.40 Start of the operational period.
(a) The operational period will start at the end of the transition
period after the parties have developed the list of conformity
assessment bodies (CAB's) found to be equivalent. The provisions of
Secs. 26.40, 26.41, 26.42, 26.43, 26.44, 26.45, and 26.46 will apply
only with regard to listed CAB's and only to the extent of any
specifications and limitations contained on the list with regard to a
CAB.
(b) The operational period will apply to quality system evaluation
reports and product evaluation reports generated by CAB's listed in
accordance with this subpart for the evaluations performed in the
respective territories of the parties, except if the parties agree
otherwise.
Sec. 26.41 Exchange and endorsement of quality system evaluation
reports.
(a) Listed European Community (EC) conformity assessment bodies
(CAB's) will provide FDA with reports of quality system evaluations, as
follows:
(1) For preapproval quality system evaluations, EC CAB's will
provide full reports; and
(2) For surveillance quality system evaluations, EC CAB's will
provide abbreviated reports.
(b) Listed U.S. CAB's will provide to the EC Notified Body of the
manufacturer's choice:
(1) Full reports of initial quality system evaluations;
(2) Abbreviated reports of quality systems surveillance audits.
(c) If the abbreviated reports do not provide sufficient
information, the importing party may request additional clarification
from the CAB.
(d) Based on the determination of equivalence in light of the
experience gained, the quality system evaluation reports prepared by
the CAB's listed as equivalent will normally be endorsed by the
importing party, except under specific and delineated circumstances.
Examples of such circumstances include indications of material
inconsistencies or inadequacies in a report, quality defects identified
in postmarket surveillance or other specific evidence of serious
concern in relation to product quality or consumer safety. In such
cases, the importing party may request clarification from the exporting
party which may lead to a request for reinspection. The parties will
endeavor to respond to requests for clarification in a timely manner.
Where divergence is not clarified in this process, the importing party
may carry out the quality system evaluation.
Sec. 26.42 Exchange and endorsement of product evaluation reports.
(a) European Community (EC) conformity assessment bodies (CAB's)
listed for this purpose will, subject to the specifications and
limitations on the list, provide to FDA 510(k) premarket notification
assessment reports prepared to U.S. medical device requirements.
(b) U.S. CAB's will, subject to the specifications and limitations
on the list, provide to the EC Notified Body of the manufacturer's
choice, type examination, and verification reports prepared to EC
medical device requirements.
(c) Based on the determination of equivalence in light of the
experience gained, the product evaluation reports prepared by the CAB's
listed as equivalent will normally be endorsed by the importing party,
except under specific and delineated circumstances. Examples of such
circumstances include indications of material inconsistencies,
inadequacies, or incompleteness in a product evaluation report, or
other specific evidence of serious concern in relation to product
safety, performance, or quality. In such cases, the importing party may
request clarification from the exporting party which may lead to a
request for a reevaluation. The parties will endeavor to respond to
requests for clarification in a timely manner. Endorsement remains the
responsibility of the importing party.
Sec. 26.43 Transmission of quality system evaluation reports.
Quality system evaluation reports covered by Sec. 26.41 concerning
products covered by this subpart shall be transmitted to the importing
party within 60 calendar days of a request by the importing party.
Should a new inspection be requested, the time period shall be extended
by an additional 30 calendar days. A party may request a new
inspection, for cause, identified to the other party. If the exporting
party cannot perform an inspection within a specified period of time,
the importing party may perform an inspection on its own.
Sec. 26.44 Transmission of product evaluation reports.
Transmission of product evaluation reports will take place
according to the importing party's specified procedures.
Sec. 26.45 Monitoring continued equivalence.
Monitoring activities will be carried out in accordance with
Sec. 26.69.
Sec. 26.46 Listing of additional CAB's.
(a) During the operational phase, additional conformity assessment
bodies (CAB's) will be considered for equivalence using the procedures
and criteria described in Secs. 26.36, 26.37, and 26.39, taking into
account the level of confidence gained in the overall regulatory system
of the other party.
(b) Once a designating authority considers that such CAB's, having
undergone the procedures of Secs. 26.36, 26.37, and 26.39, may be
determined to be equivalent, it will then designate those bodies on an
annual basis. Such procedures satisfy the procedures of Sec. 26.66(a)
and (b).
(c) Following such annual designations, the procedures for
confirmation of CAB's under Sec. 26.66(c) and (d) shall apply.
Sec. 26.47 Role and composition of the Joint Sectoral Committee.
(a) The Joint Sectoral Committee for this subpart is set up to
monitor the activities under both the transitional and operational
phases of this subpart.
(b) The Joint Sectoral Committee will be cochaired by a
representative of the Food and Drug Administration (FDA) for the United
States and a representative of the European Community (EC) who will
each have one vote. Decisions will be taken by unanimous consent.
(c) The Joint Sectoral Committee's functions will include:
(1) Making a joint assessment of the equivalence of conformity
assessment bodies (CAB's);
(2) Developing and maintaining the list of equivalent CAB's,
including any limitation in terms of their scope of activities and
communicating the list to all authorities and the Joint Committee
described in subpart C of this part;
(3) Providing a forum to discuss issues relating to this subpart,
including concerns that a CAB may no longer be equivalent and
opportunity to review product coverage; and
(4) Consideration of the issue of suspension.
Sec. 26.48 Harmonization.
During both the transitional and operational phases of this
subpart, both parties intend to continue to participate in the
activities of the Global Harmonization Task Force and utilize the
results of those activities to the extent possible. Such participation
involves developing and reviewing documents developed by the Global
Harmonization Task Force and jointly determining whether they are
applicable to the implementation of this subpart.
Sec. 26.49 Regulatory cooperation.
(a) The parties and authorities shall inform and consult with one
another, as permitted by law, of proposals to
[[Page 17755]]
introduce new controls or to change existing technical regulations or
inspection procedures and to provide the opportunity to comment on such
proposals.
(b) The parties shall notify each other in writing of any changes
to Appendix A of this subpart.
Sec. 26.50 Alert system and exchange of postmarket vigilance reports.
(a) An alert system will be set up during the transition period and
maintained thereafter by which the parties will notify each other when
there is an immediate danger to public health. Elements of such a
system will be described in an Appendix F of this subpart. As part of
that system, each party shall notify the other party of any confirmed
problem reports, corrective actions, or recalls. These reports are
regarded as part of ongoing investigations.
(b) Contact points will be agreed between both parties to permit
authorities to be made aware with the appropriate speed in case of
quality defect, batch recalls, counterfeiting and other problems
concerning quality, which could necessitate additional controls or
suspension of the distribution of the product.
Appendix A of Subpart B--Relevant Legislation, Regulations and
Procedures
1. For the European Community (EC) the following legislation applies to
Sec. 26.42(a) of this subpart:
[Copies of EC documents may be obtained from the European
Document Research, 1100 17th St. NW., suite 301, Washington, DC
20036.]
a. Council Directive 90/385/EEC of 20 June 1990 on active
implantable medical devices
OJ No. L 189, 20.7. 1990, p. 17. Conformity assessment
procedures.
Annex 2 (with the exception of section 4)
Annex 4
Annex 5
b. Council Directive 93/42/EEC of 14 June 1993 on Medical Devices OJ
No. L 169,12.7.1993, p.1. Conformity assessment procedures.
Annex 2 (with the exception of section 4)
Annex 3
Annex 4
Annex 5
Annex 6
2. For the United States, the following legislation applies to
Sec. 26.32(a):
[Copies of FDA documents may be obtained from the Government
Printing Office, 1510 H St. NW., Washington, DC 20005. FDA documents
may be viewed on FDA's Internet web site at ``http://www.fda.gov''.]
a. The Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321 et seq.
b. The Public Health Service Act, 42 U.S.C. 201 et seq.
c. Regulations of the United States Food and Drug Administration
found at 21 CFR, in particular, Parts 800 to 1299.
d. Medical Devices; Third Party Review of Selected Premarket
Notifications; Pilot Program, 61 FR 14789-14796 (April 3, 1996).
Appendix B of Subpart B--Scope of Product Coverage
1. Initial Coverage of the Transition Period
Upon entry into force of this subpart as described in Sec. 26.80 (it
is understood that the date of entry into force will not occur prior
to June 1, 1998, unless the parties decide otherwise), products
qualifying for the transitional arrangements under this subpart
include:
a. All Class I products requiring premarket evaluations in the
United States--see Table 1.
b. Those Class II products listed in Table 2.
2. During the Transition Period
The parties will jointly identify additional product groups,
including their related accessories, in line with their respective
priorities as follows:
a. Those for which review may be based primarily on written
guidance which the parties will use their best efforts to prepare
expeditiously; and
b. Those for which review may be based primarily on
international standards, in order for the parties to gain the
requisite experience.
The corresponding additional product lists will be phased in on an
annual basis. The parties may consult with industry and other
interested parties in determining which products will be added.
3. Commencement of the Operational Period
a. At the commencement of the operational period, product
coverage shall extend to all Class I/II products covered during the
transition period.
b. FDA will expand the program to categories of Class II devices
as is consistent with the results of the pilot, and with FDA's
ability to write guidance documents if the device pilot for the
third party review of medical devices is successful. The MRA will
cover to the maximum extent feasible all Class II devices listed in
Table 3 for which FDA-accredited third party review is available in
the United States.
4. Unless explicitly included by joint decision of the parties, this
part does not cover any U.S. Class II-tier 3 or any Class III product
under either system.
[FDA is codifying the lists of medical devices contained in the
following tables as they appear in the medical device annex of the
``Agreement on Mutual Recognition Between the United States of
America and the European Community.'' As a result of the Food and
Drug Administration Modernization Act of 1997, however, the medical
devices included in these tables will change.]
Table 1.--Class I Products Requiring Premarket Evaluations in the United
States, Included in Scope of Product Coverage at Beginning of Transition
Period\1\
------------------------------------------------------------------------
21 CFR Section No. Regulation Name
------------------------------------------------------------------------
Product Code--Device Name
------------------------------------------------------------------------
Anesthesiology Panel (21 CFR Part
868)
868.1910 Esophageal Stethoscope
BZW--Stethoscope, Esophageal
868.5620 Breathing Mouthpiece
BYP--Mouthpiece, Breathing
868.5640 Medicinal Nonventilatory
Nebulizer (Atomizer)
CCQ--Nebulizer, Medicinal,
Nonventilatory (Atomizer)
868.5675 Rebreathing Device
BYW--Device, Rebreathing
868.5700 Nonpowered Oxygen Tent
FOG--Hood, Oxygen, Infant
BYL--Tent, Oxygen
868.6810 Tracheobronchial Suction Catheter
BSY--Catheters, Suction,
Tracheobronchial
[[Page 17756]]
Cardiovascular Panel
(None)
Dental Panel (21 CFR Part 872)
872.3400 Karaya and Sodium Borate With or
Without Acacia Denture Adhesive
KOM--Adhesive, Denture, Acacia
and Karaya With Sodium Borate
872.3700 Dental Mercury (U.S.P.)
ELY--Mercury
872.4200 Dental Handpiece and Accessories
EBW--Controller, Food, Handpiece
and Cord
EFB--Handpiece, Air-Powered,
Dental
EFA--Handpiece, Belt and/or Gear
Driven, Dental
EGS--Handpiece, Contra- and Right-
Angle Attachment, Dental
EKX--Handpiece, Direct Drive, AC-
Powered
EKY--Handpiece, Water-Powered
872.6640 Dental Operative Unit and
Accessories
EIA--Unit, Operative Dental
Ear, Nose, and Throat Panel (21 CFR
Part 874)
874.1070 Short Increment Sensitivity Index
(SISI) Adapter
ETR--Adapter, Short Increment
Sensitivity Index (SISI)
874.1500 Gustometer
ETM--Gustometer
874.1800 Air or Water Caloric Stimulator
KHH--Stimulator, Caloric-Air
ETP--Stimulator, Caloric-Water
874.1925 Toynbee Diagnostic Tube
ETK--Tube, Toynbee Diagnostic
874.3300 Hearing Aid
LRB--Face Plate Hearing-Aid
ESD--Hearing-aid, Air-Conduction
874.4100 Epistaxis Balloon
EMX--Balloon, Epistaxis
874.5300 ENT Examination and Treatment
Unit
ETF--Unit, Examining/Treatment,
ENT
874.5550 Powered Nasal Irrigator
KMA--Irrigator, Powered Nasal
874.5840 Antistammering Device
KTH--Device, Anti-Stammering
Gastroenterology--Urology Panel (21
CFR Part 876)
876.5160 Urological Clamp for Males
FHA--Clamp, Penile
876.5210 Enema Kit
FCE--Kit, Enema, (for Cleaning
Purpose)
876.5250 Urine Collector and Accessories
FAQ--Bag, Urine Collection, Leg,
for External Use
General Hospital Panel (21 CFR Part
880)
880.5270 Neonatal Eye Pad
FOK--Pad, Neonatal Eye
880.5420 Pressure Infusor for an I.V. Bag
KZD--Infusor, Pressure, for I.V.
Bags
880.5680 Pediatric Position Holder
FRP--Holder, Infant Position
880.6250 Patient Examination Glove
LZB--Finger Cot
FMC--Glove, Patient Examination
LYY--Glove, Patient Examination,
Latex
LZA--Glove, Patient Examination,
Poly
LZC--Glove, Patient Examination,
Speciality
LYZ--Glove, Patient Examination,
Vinyl
880.6375 Patient Lubricant
KMJ--Lubricant, Patient
880.6760 Protective Restraint
BRT--Restraint, Patient,
Conductive
FMQ--Restraint, Protective
Neurology Panel (21 CFR Part 882)
882.1030 Ataxiagraph
GWW--Ataxiagraph
882.1420 Electroencephalogram (EEG) Signal
Spectrum Analyzer
GWS--Analyzer, Spectrum,
Electroencephalogram Signal
[[Page 17757]]
882.4060 Ventricular Cannula
HCD--Cannula, Ventricular
882.4545 Shunt System Implantation
Instrument
GYK--Instrument, Shunt System
Implantation
882.4650 Neurosurgical Suture Needle
HAS--Needle, Neurosurgical Suture
882.4750 Skull Punch
GXJ--Punch, Skull
Obstetrics and Gynecology Panel
(None)
Ophthalmology Panel (21 CFR Part 886)
886.1780 Retinoscope
HKM--Retinoscope, Battery-Powered
886.1940 Tonometer Sterilizer
HKZ--Sterilizer, Tonometer
886.4070 Powered Corneal Burr
HQS--Burr, Corneal, AC-Powered
HOG--Burr, Corneal, Battery-
Powered
HRG--Engine, Trephine,
Accessories, AC-Powered
HFR--Engine, Trephine,
Accessories, Battery-Powered
HLD--Engine, Trephine,
Accessories, Gas-Powered
886.4370 Keratome
HNO--Keratome, AC-Powered
HMY--Keratome, Battery-Powered
886.5850 Sunglasses (Nonprescription)
HQY--Sunglasses (Nonprescription
Including Photosensitive)
Orthopedic Panel (21 CFR Part 888)
888.1500 Goniometer
KQX--Goniometer, AC-Powered
888.4150 Calipers for Clinical Use
KTZ--Caliper
Physical Medicine Panel (21 CFR Part
890)
890.3850 Mechanical Wheelchair
LBE--Stroller, Adaptive
IOR--Wheelchair, Mechanical
890.5180 Manual Patient Rotation Bed
INY--Bed, Patient Rotation,
Manual
890.5710 Hot or Cold Disposable Pack
IMD--Pack, Hot or Cold,
Disposable
Radiology Panel (21 CFR Part 892)
892.1100 Scintillation (Gamma) Camera
IYX--Camera, Scintillation
(Gamma)
892.1110 Positron Camera
IZC--Camera, Positron
892.1300 Nuclear Rectilinear Scanner
IYW--Scanner, Rectilinear,
Nuclear
892.1320 Nuclear Uptake Probe
IZD--Probe, Uptake, Nuclear
892.1330 Nuclear Whole Body Scanner
JAM--Scanner, Whole Body, Nuclear
892.1410 Nuclear Electrocardiograph
Synchronizer
IVY--Synchronizer,
Electrocardiograph, Nuclear
892.1890 Radiographic Film Illuminator
IXC--Illuminator, Radiographic-
Film
JAG--Illuminator, Radiographic-
Film, Explosion-Proof
892.1910 Radiographic Grid
IXJ--Grid, Radiographic
892.1960 Radiographic Intensifying Screen
WAM--Screen, Intensifying,
Radiographic
892.1970 Radiographic ECG/Respirator
Synchronizer
IXO--Synchronizer, ECG/
Respirator, Radiographic
892.5650 Manual Radionuclide Applicator
System
IWG--System, Applicator,
Radionuclide, Manual
General and Plastic Surgery Panel (21
CFR Part 878)
878.4200 Introduction/Drainage Catheter
and Accessories
KGZ--Accessories, Catheter
GCE--Adaptor, Catheter
FGY--Cannula, Injection
GBA--Catheter, Balloon Type
[[Page 17758]]
GBZ--Catheter, Cholangiography
GBQ--Catheter, Continuous
Irrigation
GBY--Catheter, Eustachian,
General & Plastic Surgery
JCY--Catheter, Infusion
GBX--Catheter, Irrigation
GBP--Catheter, Multiple Lumen
GBO--Catheter, Nephrostomy,
General & Plastic Surgery
GBN--Catheter, Pediatric, General
& Plastic Surgery
GBW--Catheter, Peritoneal
GBS--Catheter, Ventricular,
General & Plastic Surgery
GCD--Connector, Catheter
GCC--Dilator, Catheter
GCB--Needle, Catheter
878.4320 Removable Skin Clip
FZQ--Clip, Removable (Skin)
878.4460 Surgeon's Gloves
KGO--Surgeon's Gloves
878.4680 Nonpowered, Single Patient,
Portable Suction Apparatus
GCY--Apparatus, Suction, Single
Patient Use, Portable,
Nonpowered
878.4760 Removable Skin Staple
GDT--Staple, Removable (Skin)
878.4820 AC-Powered, Battery-Powered, and
Pneumatically Powered Surgical
Instrument Motors and
Accessories/Attachments
GFG--Bit, Surgical
GFA--Blade, Saw, General &
Plastic Surgery
DWH--Blade, Saw, Surgical,
Cardiovascular
BRZ--Board, Arm (With Cover)
GFE--Brush, Dermabrasion
GFF--Bur, Surgical, General &
Plastic Surgery
KDG--Chisel (Osteotome)
GFD--Dermatome
GFC--Driver, Surgical, Pin
GFB--Head, Surgical, Hammer
GEY--Motor, Surgical Instrument,
AC-Powered
GET--Motor, Surgical Instrument,
Pneumatic Powered
DWI--Saw, Electrically Powered
KFK--Saw, Pneumatically Powered
HAB--Saw, Powered, and
Accessories
878.4960 Air or AC-Powered Operating Table
and Air or AC-Powered Operating
Chair & Accessories
GBB--Chair, Surgical, AC-Powered
FQO--Table, Operating-Room, AC-
Powered
GDC--Table, Operating-Room,
Electrical
FWW--Table, Operating-Room,
Pneumatic
JEA--Table, Surgical with
Orthopedic Accessories, AC-
Powered
880.5090 Liquid Bandage
KMF--Bandage, Liquid
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
medical device identifiers may be viewed on FDA's Internet Web Site at
``http://www.fda.gov/cdrh/prodcode.html''.
Table 2.--Class II Medical Devices Included in Scope of Product Coverage
at Beginning of Transition Period (United States to develop guidance
documents identifying U.S. requirements and European Community (EC) to
identify standards needed to meet EC requirements)\1\
------------------------------------------------------------------------
Panel 21 CFR Section Regulation Name
---------------- No. --------------------------------------
------------------
Product Code--Device Name
------------------------------------------------------------------------
RA 892.1000 Magnetic Resonance Diagnostic Device
MOS--COIL, Magnetic Resonance,
Specialty
LNH--System, Nuclear Magnetic
Resonance Imaging
LNI--System, Nuclear Magnetic
Resonance Spectroscopic
Diagnostic
Ultrasound:
RA 892.1540 Nonfetal Ultrasonic Monitor
JAF--Monitor, Ultrasonic, Nonfetal
RA 892.1550 Ultrasonic Pulsed Doppler Imaging
System
IYN--System, Imaging, Pulsed Doppler,
Ultrasonic
[[Page 17759]]
RA 892.1560 Ultrasonic Pulsed Echo Imaging System
................ IYO--System, Imaging, Pulsed Echo,
Ultrasonic
RA 892.1570 Diagnostic Ultrasonic Transducer
................ ITX--Transducer, Ultrasonic,
Diagnostic
Diagnostic X-
Ray Imaging
Devices
(except
mammographic x-
ray systems):
RA 892.1600 Angiographic X-Ray System
IZI--System, X-Ray, Angiographic
RA 892.1650 Image-Intensified Fluoroscopic X-Ray
System
MQB--Solid State X-Ray Imager (Flat
Panel/Digital Imager)
JAA--System, X-Ray, Fluoroscopic,
Image-Intensified
RA 892.1680 Stationary X-Ray System
KPR--System, X-Ray, Stationary
RA 892.1720 Mobile X-Ray System
IZL--System, X-Ray, Mobile
RA 892.1740 Tomographic X-Ray System
IZF--System, X-Ray, Tomographic
RA 892.1750 Computed Tomography X-Ray System
JAK--System, X-Ray, Tomography,
Computed
ECG-Related
Devices:
CV 870.2340 Electrocardiograph
................ DPS--Electrocardiograph
................ MLC--Monitor, ST Segment
CV 870.2350 Electrocardiograph Lead Switching
Adaptor
DRW--Adaptor, Lead Switching,
Electrocardiograph
CV 870.2360 Electrocardiograph Electrode
DRX--Electrode, Electrocardiograph
CV 870.2370 Electrocardiograph Surface Electrode
Tester
KRC--Tester, Electrode, Surface,
Electrocardiographic
NE 882.1400 Electroencephalograph
GWQ--Electroencephalograph
HO 880.5725 Infusion Pump (external only)
MRZ--Accessories, Pump, Infusion
FRN--Pump, Infusion
LZF--Pump, Infusion, Analytical
Sampling
MEB--Pump, Infusion, Elastomeric
LZH--Pump, Infusion, Enteral
MHD--Pump, Infusion, Gallstone
Dissolution
LZG--Pump, Infusion, Insulin
MEA--Pump, Infusion, PCA
Ophthalmic
Instruments:
OP 886.1570 Ophthalmoscope
HLI--Ophthalmoscope, AC-Powered
HLJ--Ophthalmoscope, Battery-Powered
OP 886.1780 Retinoscope
HKL--Retinoscope, AC-Powered
OP 886.1850 AC-Powered Slit-Lamp Biomicroscope
HJO--Biomicroscope, Slit-Lamp, AC-
Powered
OP 886.4150 Vitreous Aspiration and Cutting
Instrument
MMC--Dilator, Expansive Iris
(Accessory)
HQE--Instrument, Vitreous Aspiration
and Cutting, AC-Powered
HKP--Instrument, Vitreous Aspiration
and Cutting, Battery-Powered
MLZ--Vitrectomy, Instrument Cutter
OP 886.4670 Phacofragmentation System
HQC--Unit, Phacofragmentation
SU 878.4580 Surgical Lamp
HBI--Illuminator, Fiberoptic,
Surgical Field
FTF--Illuminator, Nonremote
FTG--Illuminator, Remote
HJE--Lamp, Fluorescein, AC-Powered
FQP--Lamp, Operating-Room
FTD--Lamp, Surgical
GBC--Lamp, Surgical, Incandescent
FTA--Light, Surgical, Accessories
FSZ--Light, Surgical, Carrier
FSY--Light, Surgical, Ceiling Mounted
[[Page 17760]]
FSX--Light, Surgical, Connector
FSW--Light, Surgical, Endoscopic
FST--Light, Surgical, Fiberoptic
FSS--Light, Surgical, Floor Standing
FSQ--Light, Surgical, Instrument
NE 882.5890 Transcutaneous Electrical Nerve
Stimulator for Pain Relief
GZJ--Stimulator, Nerve,
Transcutaneous, For Pain Relief
Noninvasive Blood Pressure
Measurement Devices:
CV 870.1120 Blood Pressure Cuff
DXQ--Cuff, Blood-Pressure
CV 870.1130 Noninvasive Blood Pressure
Measurement System (except
nonoscillometric)
DXN--System, Measurement, Blood-
Pressure, Noninvasive
HO 880.6880 Steam Sterilizer (greater than 2
cubic feet)
FLE--Sterilizer, Steam
Clinical
Thermometers:
HO 880.2910 Clinical Electronic Thermometer
(except tympanic or pacifier)
FLL--Thermometer, Electronic,
Clinical
AN 868.5630 Nebulizer
CAF--Nebulizer (Direct Patient
Interface)
AN 868.5925 Powered Emergency Ventilator
Hypodermic
Needles and
Syringes
(except
antistick and
self-
destruct):
HO 880.5570 Hypodermic Single Lumen Needle
MMK--Container, Sharpes
FMI--Needle, Hypodermic, Single Lumen
MHC--Port, Intraosseous, Implanted
HO 880.5860 Piston Syringe
FMF--Syringe, Piston
OR 888.3020 Intramedullary Fixation Rod
HSB--ROD, Fixation, Intramedullary
and Accessories
External
Fixators
(except
devices with
no external
components):
OR 888.3030 Single/Multiple Component Metallic
Bone Fixation Appliances and
Accessories
KTT--Appliance, Fixation, Nail/Blade/
Plate Combination, Multiple
Component
OR 888.3040 Smooth or Threaded Metallic Bone
Fixation Fastener
JEC--Component, Traction, Invasive
HTY--Pin, Fixation, Smooth
JDW--Pin, Fixation, Threaded
Selected Dental
Materials:
DE 872.3060 Gold-Based Alloys and Precious Metal
Alloys for Clinical Use
EJT--Alloy, Gold Based, For Clinical
Use
EJS--Alloy, Precious Metal, For
Clinical Use
DE 872.3200 Resin Tooth Bonding Agent
KLE--Agent, Tooth Bonding, Resin
DE 872.3275 Dental Cement
EMA--Cement, Dental
EMB--Zinc Oxide Eugenol
DE 872.3660 Impression Material
ELW--Material, Impression
DE 872.3690 Tooth Shade Resin Material
EBF--Material, Tooth Shade, Resin
DE 872.3710 Base Metal Alloy
EJH--Metal, Base
Latex Condoms:
OB 884.5300 Condom
HIS--Condom
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
medical device identifiers may be viewed on FDA's Internet Web Site at
``http://www.fda.gov/cdrh/prodcode.html''.
[[Page 17761]]
Table 3.--Medical Devices for Possible Inclusion in Scope of Product
Coverage During Operational Period\1\
------------------------------------------------------------------------
Product Family 21 CFR Section No Device Name Tier
------------------------------------------------------------------------
Anesthesiology
Panel
Anesthesia 868.5160 Gas machine for 2
Devices anesthesia or
analgesia
868.5270 Breathing system 2
heater
868.5440 Portable oxygen 2
generator
868.5450 Respiratory gas 2
humidifier
868.5630 Nebulizer 2
868.5710 Electrically 2
powered oxygen
tent
868.5880 Anesthetic 2
vaporizer
Gas Analyser 868.1040 Powered 2
Algesimeter
868.1075 Argon gas 2
analyzer
868.1400 Carbon dioxide 2
gas analyzer
868.1430 Carbon monoxide 2
gas analyzer
868.1500 Enflurane gas 2
analyzer
868.1620 Halothane gas 2
analyzer
868.1640 Helium gas 2
analyzer
868.1670 Neon gas 2
analyzer
868.1690 Nitrogen gas 2
analyzer
868.1700 Nitrous oxide 2
gas analyzer
868.1720 Oxygen gas 2
analyzer
868.1730 Oxygen uptake 2
computer
Peripheral 868.2775 Electrical 2
Nerve peripheral
Stimulators nerve
stimulator
Respiratory 868.1750 Pressure 2
Monitoring plethysmograph
868.1760 Volume 2
plethysmograph
868.1780 Inspiratory 2
airway pressure
meter
868.1800 Rhinoanemometer 2
868.1840 Diagnostic 2
spirometer
868.1850 Monitoring 2
spirometer
868.1860 Peak-flow meter 2
for spirometry
868.1880 Pulmonary- 2
function data
calculator
868.1890 Predictive 2
pulmonary-
function value
calculator
868.1900 Diagnostic 2
pulmonary-
function
interpretation
calculator
868.2025 Ultrasonic air 2
embolism
monitor
868.2375 Breathing 2
frequency
monitor (except
apnea
detectors)
868.2480 Cutaneous carbon 2
dioxide (PcCO2)
monitor
868.2500 Cutaneous oxygen 2
monitor (for an
infant not
under gas
anesthesia)
868.2550 Pneumotachomomet 2
er
868.2600 Airway pressure 2
monitor
868.5665 Powered 2
percussor
868.5690 Incentive 2
spirometer
Ventilator 868.5905 Noncontinuous 2
ventilator
(IPPB)
868.5925 Powered 2
emergency
ventilator
868.5935 External 2
negative
pressure
ventilator
868.5895 Continuous 2
ventilator
868.5955 Intermittent 2
mandatory
ventilation
attachment
868.6250 Portable air 2
compressor
Cardiovascular
Panel
Cardiovascula 870.1425 Programmable 2
r Diagnostic diagnostic
computer
870.1450 Densitometer 2
870.2310 Apex cardiograph 2
(vibrocardiogra
ph)
870.2320 Ballistocardiogr 2
aph
870.2340 Electrocardiogra 2
ph
870.2350 Electrocardiogra 1
ph lead
switching
adaptor
870.2360 Electrocardiogra 2
ph electrode
870.2370 Electrocardiogra 2
ph surface
electrode
tester
870.2400 Vectorcardiograp 1
h
870.2450 Medical cathode- 1
ray tube
display
[[Page 17762]]
870.2675 Oscillometer 2
870.2840 Apex 2
cardiographic
transducer
870.2860 Heart sound 2
transducer
Cardiovascula Valve, pressure
r Monitoring relief,
cardiopulmonary
bypass
870.1100 Blood pressure 2
alarm
870.1110 Blood pressure 2
computer
870.1120 Blood pressure 2
cuff
870.1130 Noninvasive 2
blood pressure
measurement
system
870.1140 Venous blood 2
pressure
manometer
870.1220 Electrode 2
recording
catheter or
electrode
recording probe
870.1270 Intracavitary 2
phonocatheter
system
870.1875 Stethoscope 2
(electronic)
870.2050 Biopotential 2
amplifier and
signal
conditioner
870.2060 Transducer 2
signal
amplifier and
conditioner
870.2100 Cardiovascular 2
blood flow-
meter
870.2120 Extravascular 2
blood flow
probe
870.2300 Cardiac monitor 2
(including
cardiotachomete
r and rate
alarm)
870.2700 Oximeter 2
870.2710 Ear oximeter 2
870.2750 Impedance 2
phlebograph
870.2770 Impedance 2
plethysmograph
870.2780 Hydraulic, 2
pneumatic, or
photoelectric
plethysmographs
870.2850 Extravascular 2
blood pressure
transducer
870.2870 Catheter tip 2
pressure
transducer
870.2880 Ultrasonic 2
transducer
870.2890 Vessel occlusion 2
transducer
870.2900 Patient 2
transducer and
electrode cable
(including
connector)
870.2910 Radiofrequency 2
physiological
signal
transmitter and
receiver
870.2920 Telephone 2
electrocardiogr
aph transmitter
and receiver
870.4205 Cardiopulmonary 2
bypass bubble
detector
870.4220 Cardiopulmonary 2
bypass heart-
lung machine
console
870.4240 Cardiovascular 2
bypass heat
exchanger
870.4250 Cardiopulmonary 2
bypass
temperature
controller
870.4300 Cardiopulmonary 2
bypass gas
control unit
870.4310 Cardiopulmonary 2
bypass coronary
pressure gauge
870.4330 Cardiopulmonary 2
bypass on-line
blood gas
monitor
870.4340 Cardiopulmonary 2
bypass level
sensing monitor
and/or control
870.4370 Roller-type 2
cardiopulmonary
bypass blood
pump
870.4380 Cardiopulmonary 2
bypass pump
speed control
870.4410 Cardiopulmonary 2
bypass in-line
blood gas
sensor
Cardiovascula 870.5050 Patient care 2
r suction
Therapeutic apparatus
870.5900 Thermal 2
regulation
system
Defibrillator 870.5300 DC- 2
defribrillator
(including
paddles)
870.5325 Defibrillator 2
tester
[[Page 17763]]
Echocardiogra 870.2330 Echocardiograph 2
ph
Pacemaker & 870.1750 External 2
Accessories programmable
pacemaker pulse
generator
870.3630 Pacemaker 2
generator
function
analyzer
870.3640 Indirect 2
pacemaker
generator
function
analyzer
870.3720 Pacemaker 2
electrode
function tester
Miscellaneous 870.1800 Withdrawal- 2
infusion pump
870.2800 Medical magnetic 2
tape recorder
None Batteries,
rechargeable,
class II
devices
Dental Panel
Dental 872.1720 Pulp tester 2
Equipment
872.1740 Caries detection 2
device
872.4120 Bone cutting 2
instrument and
accessories
872.4465 Gas-powered jet 2
injector
872.4475 Spring-powered 2
jet injector
872.4600 Intraoral 2
ligature and
wire lock
872.4840 Rotary scaler 2
872.4850 Ultrasonic 2
scaler
872.4920 Dental 2
electrosurgical
unit and
accessories
872.6070 Ultraviolet 2
activator for
polymerization
872.6350 Ultraviolet 2
detector
Dental 872.3050 Amalgam alloy 2
Material
872.3060 Gold-based 2
alloys and
precious metal
alloys for
clinical use
872.3200 Resin tooth 2
bonding agent
872.3250 Calcium 2
hydroxide
cavity liner
872.3260 Cavity varnish 2
872.3275 Dental cement 2
(other than
zinc oxide-
eugenol)
872.3300 Hydrophilic 2
resin coating
for dentures
872.3310 Coating material 2
for resin
fillings
872.3590 Preformed 2
plastic denture
tooth
872.3660 Impression 2
material
872.3690 Tooth shade 2
resin material
872.3710 Base metal alloy 2
872.3750 Bracket adhesive 2
resin and tooth
conditioner
872.3760 Denture 2
relining,
repairing, or
rebasing resin
872.3765 Pit and fissure 2
sealant and
conditioner
872.3770 Temporary crown 2
and bridge
resin
872.3820 Root canal 2
filling resin
(other than
chloroform use)
872.3920 Porcelain tooth 2
Dental X-ray 872.1800 Extraoral source 2
x-ray system
872.1810 Intraoral source 2
x-ray system
Dental 872.4880 Intraosseous 2
Implants fixation screw
or wire
872.3890 Endodontic 2
stabilizing
splint
Orthodontic 872.5470 Orthodontic 2
plastic bracket
Ear/Nose/Throat
Panel
Diagnostic 874.1050 Audiometer 2
Equipment
874.1090 Auditory 2
impedance
tester
874.1120 Electronic noise 2
generator for
audiometric
testing
874.1325 Electroglottogra 2
ph
874.1820 Surgical nerve 2
stimulator/
locator
Hearing Aids 874.3300 Hearing aid (for 2
bone-
conduction)
874.3310 Hearing aid 2
calibrator and
analysis system
874.3320 Group hearing 2
aid or group
auditory
trainer
[[Page 17764]]
874.3330 Master hearing 2
aid
Surgical 874.4250 Ear, nose, and 1
Equipment throat electric
or pneumatic
surgical drill
874.4490 Argon laser for 2
otology,
rhinology, and
laryngology
874.4500 Ear, nose, and 2
throat
microsurgical
carbon dioxide
laser
Gastroenterology/
Urology Panel
Endoscope 876.1500 Endoscope and 2
(including accessories
angioscopes,
laparscopes,
ophthalmic
endoscopes)
876.4300 Endoscopic 2
electrosurgical
unit and
accessories
Gastroenterol 876.1725 Gastrointestinal 1
ogy motility
monitoring
system
Hemodialysis 876.5600 Sorbent 2
regenerated
dialysate
delivery system
for
hemodialysis
876.5630 Peritoneal 2
dialysis system
and accessories
876.5665 Water 2
purification
system for
hemodialysis
876.5820 Hemodialysis 2
system and
accessories
876.5830 Hemodialyzer 2
with disposable
insert (kiil-
type)
Lithotriptor 876.4500 Mechanical 2
lithotriptor
Urology 876.1620 Urodynamics 2
Equipment measurement
system
876.5320 Nonimplanted 2
electrical
continence
device
876.5880 Isolated kidney 2
perfusion and
transport
system and
accessories
General Hospital
Panel
Infusion 880.2420 Electronic 2
Pumps and monitor for
Systems gravity flow
infusion
systems
880.2460 Electrically 2
powered spinal
fluid pressure
monitor
880.5430 Nonelectrically 2
powered fluid
injector
880.5725 Infusion pump 2
Neonatal 880.5400 Neonatal 2
Incubators incubator
880.5410 Neonatal 2
transport
incubator
880.5700 Neonatal 2
phototherapy
unit
Piston 880.5570 Hypodermic 1
Syringes single lumen
needle
880.5860 Piston syringe 1
(except
antistick)
880.6920 Syringe needle 2
introducer
Miscellaneous 880.2910 Clinical 2
electronic
thermometer
880.2920 Clinical mercury 2
thermometer
880.5100 AC-powered 1
adjustable
hospital bed
880.5500 AC-powered 2
patient lift
880.6880 Steam sterilizer 2
(greater than 2
cubic feet)
Neurology Panel
882.1020 Rigidity 2
analyzer
882.1610 Alpha monitor 2
Neuro- 882.1320 Cutaneous 2
Diagnostic electrode
882.1340 Nasopharyngeal 2
electrode
882.1350 Needle electrode 2
882.1400 Electroencephalo 2
graph
882.1460 Nystagmograph 2
882.1480 Neurological 2
endoscope
882.1540 Galvanic skin 2
response
measurement
device
882.1550 Nerve conduction 2
velocity
measurement
device
882.1560 Skin potential 2
measurement
device
882.1570 Powered direct- 2
contact
temperature
measurement
device
[[Page 17765]]
882.1620 Intracranial 2
pressure
monitoring
device
882.1835 Physiological 2
signal
amplifier
882.1845 Physiological 2
signal
conditioner
882.1855 Electroencephalo 2
gram (EEG)
telemetry
system
882.5050 Biofeedback 2
device
Echoencephalo 882.1240 Echoencephalogra 2
graphy ph
RPG 882.4400 Radiofrequency 2
lesion
generator
Neuro Surgery none Electrode, 2
spinal epidural
882.4305 Powered compound 2
cranial drills,
burrs,
trephines, and
their
accessories
882.4310 Powered simple 2
cranial drills
burrs,
trephines, and
their
accessories
882.4360 Electric cranial 2
drill motor
882.4370 Pneumatic 2
cranial drill
motor
882.4560 Stereotaxic 2
instrument
882.4725 Radiofrequency 2
lesion probe
882.4845 Powered rongeur 2
882.5500 Lesion 2
temperature
monitor
Stimulators 882.1870 Evoked response 2
electrical
stimulator
882.1880 Evoked response 2
mechanical
stimulator
882.1890 Evoked response 2
photic
stimulator
882.1900 Evoked response 2
auditory
stimulator
882.1950 Tremor 2
transducer
882.5890 Transcutaneous 2
electrical
nerve
stimulator for
pain relief
Obstetrics/
Gynecology Panel
Fetal 884.1660 Transcervical 2
Monitoring endoscope
(amnioscope)
and accessories
884.1690 Hysteroscope and 2
accessories
(for
performance
standards)
884.2225 Obstetric- 2
gynecologic
ultrasonic
imager
884.2600 Fetal cardiac 2
monitor
884.2640 Fetal 2
phonocardiograp
hic monitor and
accessories
884.2660 Fetal ultrasonic 2
monitor and
accessories
884.2675 Fetal scalp 1
circular
(spiral)
electrode and
applicator
884.2700 Intrauterine 2
pressure
monitor and
accessories
884.2720 External uterine 2
contraction
monitor and
accessories
884.2740 Perinatal 2
monitoring
system and
accessories
884.2960 Obstetric 2
ultrasonic
transducer and
accessories
Gynecological 884.1720 Gynecologic 2
Surgery laparoscope and
Equipment accessories
884.4160 Unipolar 2
endoscopic
coagulator-
cutter and
accessories
884.4550 Gynecologic 2
surgical laser
884.4120 Gynecologic 2
electrocautery
and accessories
884.5300 Condom 2
Ophthalmic 886.3320 Eye sphere 2
Implants implant
Contact Lens 886.1385 Polymethylmethac 2
rylate (PMMA)
diagnostic
contact lens
886.5916 Rigid gas 2
permeable
contact lens
(daily wear
only)
Diagnostic 886.1120 Opthalmic camera 1
Equipment
886.1220 Corneal 1
electrode
886.1250 Euthyscope (AC- 1
powered)
886.1360 Visual field 1
laser
instrument
[[Page 17766]]
886.1510 Eye movement 1
monitor
886.1570 Ophthalmoscope 1
886.1630 AC-powered 1
photostimulator
886.1640 Ophthalmic 1
preamplifier
886.1670 Ophthalmic 2
isotope uptake
probe
886.1780 Retinoscope (AC- 1
powered device)
886.1850 AC-powered slit 1
lamp
biomicroscope
886.1930 Tonometer and 2
accessories
886.1945 Transilluminator 1
(AC-powered
device)
886.3130 Ophthalmic 2
conformer
(Diagnostic/ 886.4670 Phacofragmentati 2
Surgery on system
Equipment)
Ophthalmic 886.3340 Extraocular 2
Implants orbital implant
886.3800 Scleral shell 2
Surgical 880.5725 Infusion pump 2
Equipment (performance
standards)
886.3100 Ophthalmic 2
tantalum clip
886.3300 Absorbable 2
implant
(scleral
buckling
method)
886.4100 Radiofrequency 2
electrosurgical
cautery
apparatus
886.4115 Thermal cautery 2
unit
886.4150 Vitreous 2
aspiration and
cutting
instrument
886.4170 Cryophthalmic 2
unit
886.4250 Ophthalmic 1
electrolysis
unit (AC-
powered device)
886.4335 Operating 1
headlamp (AC-
powered device)
886.4390 Ophthalmic laser 2
886.4392 Nd:YAG laser for 2
posterior
capsulotomy
886.4400 Electronic metal 1
locator
886.4440 AC-powered 1
magnet
886.4610 Ocular pressure 2
applicator
886.4690 Ophthalmic 2
photocoagulator
886.4790 Ophthalmic 2
sponge
886.5100 Ophthalmic beta 2
radiation
source
none Ophthalmoscopes, 1
replacement
batteries, hand-
held
Orthopedic Panel
Implants 888.3010 Bone fixation 2
cerclage
888.3020 Intramedullary 2
fixation rod
888.3030 Single/multiple 2
component
metallic bone
fixation
appliances and
accessories
888.3040 Smooth or 2
threaded
metallic bone
fixation
fastener
888.3050 Spinal 2
interlaminal
fixation
orthosis
888.3060 Spinal 2
intervertebral
body fixation
orthosis
Surgical 888.1240 AC-powered 2
Equipment dynamometer
888.4580 Sonic surgical 2
instrument and
accessories/
attachments
none Accessories, 2
fixation,
spinal
interlaminal
none Accessories, 2
fixation,
spinal
intervertebral
body
none Monitor, 1
pressure,
intracompartmen
tal
none Orthosis, 2
fixation,
spinal
intervertebral
fusion
none Orthosis, spinal
pedicle
fixation
none System, cement 1
removal
extraction
[[Page 17767]]
Physical Medicine
Panel
Diagnostic 890.1225 Chronaximeter 2
Equipment or
(Therapy)
Therapeutic
Equipment
890.1375 Diagnostic 2
electromyograph
890.1385 Diagnostic 2
electromyograph
needle
electrode
890.1450 Powered reflex 2
hammer
890.1850 Diagnostic 2
muscle
stimulator
or (Therapy) 890.5850 Powered muscle 2
stimulator
Therapeutic 890.5100 Immersion 2
Equipment hydrobath
890.5110 Paraffin bath 2
890.5500 Infrared lamp 2
890.5720 Water 2
circulating hot
or cold pack
890.5740 Powered heating 2
pad
Radiology Panel
MRI 892.1000 Magnetic 2
resonance
diagnostic
device
Ultrasound 884.2660 Fetal ultrasonic 2
Diagnostic monitor and
accessories
892.1540 Nonfetal
ultrasonic
monitor
892.1560 Ultrasonic 2
pulsed echo
imaging system
892.1570 Diagnostic 2
ultrasonic
transducer
892.1550 Ultrasonic
pulsed doppler
imaging system
Angiographic 892.1600 Angiographic x- 2
ray system
Diagnostic X- 892.1610 Diagnostic x-ray 2
Ray beam-limiting
device
892.1620 Cine or spot 2
fluorographic x-
ray camera
892.1630 Electrostatic x- 2
ray imaging
system
892.1650 Image- 2
intensified
fluoroscopic x-
ray system
892.1670 Spot film device 2
892.1680 Stationary x-ray 2
system
892.1710 Mammographic x- 2
ray system
892.1720 Mobile x-ray 2
system
892.1740 Tomographic x- 1
ray system
892.1820 Pneumoencephalog 2
raphic chair
892.1850 Radiographic 1
film cassette
892.1860 Radiographic 1
film/cassette
changer
892.1870 Radiographic 2
film/cassette
changer
programmer
892.1900 Automatic 2
radiographic
film processor
892.1980 Radiologic table 1
CT Scanner 892.1750 Computed 2
tomography x-
ray system
Radiation 892.5050 Medical charged- 2
Therapy particle
radiation
therapy system
892.5300 Medical neutron 2
radiation
therapy system
892.5700 Remote 2
controlled
radionuclide
applicator
system
892.5710 Radiation 2
therapy beam-
shaping block
892.5730 Radionuclide 2
brachytherapy
source
892.5750 Radionuclide 2
radiation
therapy system
892.5770 Powered 2
radiation
therapy patient
support
assembly
892.5840 Radiation 2
therapy
simulation
system
892.5930 Therapeutic x- 1
ray tube
housing
assembly
Nuclear 892.1170 Bone 2
Medicine densitometer
892.1200 Emission 2
computed
tomography
system
[[Page 17768]]
892.1310 Nuclear 1
tomography
system
892.1390 Radionuclide 2
rebreathing
system
General/Plastic
Surgery Panel
Surgical 878.4630 Ultraviolet lamp 2
Lamps for
dermatologic
disorders
890.5500 Infrared lamp 2
878.4580 Surgical lamp 2
Electrosurgic 878.4810 Laser surgical 2
al Cutting instrument for
Equipment use in general
and plastic
surgery and in
dermatology
878.4400 Electrosurgical 2
cutting and
coagulation
device and
accessories
Miscellaneous 878.4780 Powered suction 2
pump
------------------------------------------------------------------------
\1\Descriptive information on product codes, panel codes, and other
medical device identifiers may be viewed on FDA's Internet Web Site at
``http://www.fda.gov/cdrh/prodcode.html''.
Appendix C of Subpart B [Reserved]
Appendix D of Subpart B [Reserved]
Appendix E of Subpart B [Reserved]
Appendix F of Subpart B [Reserved]
Subpart C--Framework or ``Umbrella'' Provisions
Sec. 26.60 Definitions.
(a) The following terms and definitions shall apply to this part
only:
(1) Designating Authority means a body with power to designate,
monitor, suspend, remove suspension of, or withdraw conformity
assessment bodies as specified under this part.
(2) Designation means the identification by a designating authority
of a conformity assessment body to perform conformity assessment
procedures under this part.
(3) Regulatory Authority means a government agency or entity that
exercises a legal right to control the use or sale of products within a
party's jurisdiction and may take enforcement action to ensure that
products marketed within its jurisdiction comply with legal
requirements.
(b) Other terms concerning conformity assessment used in this part
shall have the meaning given elsewhere in this part or in the
definitions contained in Guide 2 (1996 edition) of the International
Organization for Standardization (ISO) and the International
Electrotechnical Commission (IEC). In the event of an inconsistency
between the ISO/IEC Guide 2 and definitions in this part, the
definitions in this part shall prevail. The ISO/IEC Guide 2 is
incorporated by reference with the approval of the Director of the
Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Copies are available from the International Organization for
Standardization, 1, rue de Varembe, Case postale 56, CH-1211 Geneve 20,
Switzerland, or on the Internet at ``http://www.iso.ch'' or may be
examined at the Food and Drug Administration's Medical Library, 5600
Fishers Lane, rm. 11B-40, Rockville, MD 20857, or the Office of the
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
Sec. 26.61 Purpose of this part.
This part specifies the conditions by which each party will accept
or recognize results of conformity assessment procedures, produced by
the other party's conformity assessment bodies (CAB's) or authorities,
in assessing conformity to the importing party's requirements, as
specified on a sector-specific basis in subparts A and B of this part,
and to provide for other related cooperative activities. The objective
of such mutual recognition is to provide effective market access
throughout the territories of the parties with regard to conformity
assessment for all products covered under this part. If any obstacles
to such access arise, consultations will promptly be held. In the
absence of a satisfactory outcome of such consultations, the party
alleging its market access has been denied, may, within 90 days of such
consultation, invoke its right to terminate this part in accordance
with Sec. 26.80.
Sec. 26.62 General obligations.
(a) The United States shall, as specified in subparts A and B of
this part, accept or recognize results of specified procedures, used in
assessing conformity to specified legislative, regulatory, and
administrative provisions of the United States, produced by the other
party's conformity assessment bodies (CAB's) and/or authorities.
(b) The European Community (EC) and its Member States shall, as
specified in subparts A and B of this part, accept or recognize results
of specified procedures, used in assessing conformity to specified
legislative, regulatory, and administrative provisions of the EC and
its Member States, produced by the other party's CAB's and/or
authorities.
(c) Where sectoral transition arrangements have been specified in
subparts A and B of this part, the above obligations will apply
following the successful completion of those sectoral transition
arrangements, with the understanding that the conformity assessment
procedures utilized assure conformity to the satisfaction of the
receiving party, with applicable legislative, regulatory, and
administrative provisions of that party, equivalent to the assurance
offered by the receiving party's own procedures.
Sec. 26.63 General coverage of this part.
(a) This part applies to conformity assessment procedures for
products and/or processes and to other related cooperative activities
as described in this part.
(b) Subparts A and B of this part may include:
(1) A description of the relevant legislative, regulatory, and
administrative provisions pertaining to the conformity assessment
procedures and technical regulations;
(2) A statement on the product scope and coverage;
(3) A list of designating authorities;
(4) A list of agreed conformity assessment bodies (CAB's) or
authorities or a source from which to obtain a list of such bodies or
authorities and a statement of the scope of the conformity assessment
procedures for which each has been agreed;
(5) The procedures and criteria for designating the CAB's;
[[Page 17769]]
(6) A description of the mutual recognition obligations;
(7) A sectoral transition arrangement;
(8) The identity of a sectoral contact point in each party's
territory; and
(9) A statement regarding the establishment of a Joint Sectoral
Committee.
(c) This part shall not be construed to entail mutual acceptance of
standards or technical regulations of the parties and, unless otherwise
specified in subpart A or B of this part, shall not entail the mutual
recognition of the equivalence of standards or technical regulations.
Sec. 26.64 Transitional arrangements.
The parties agree to implement the transitional commitments on
confidence building as specified in subparts A and B of this part.
(a) The parties agree that each sectoral transitional arrangement
shall specify a time period for completion.
(b) The parties may amend any transitional arrangement by mutual
agreement.
(c) Passage from the transitional phase to the operational phase
shall proceed as specified in subparts A and B of this part, unless
either party documents that the conditions provided in such subpart for
a successful transition are not met.
Sec. 26.65 Designating authorities.
The parties shall ensure that the designating authorities specified
in subpart B of this part have the power and competence in their
respective territories to carry out decisions under this part to
designate, monitor, suspend, remove suspension of, or withdraw
conformity assessment bodies (CAB's).
Sec. 26.66 Designation and listing procedures.
The following procedures shall apply with regard to the designation
of conformity assessment bodies (CAB's) and the inclusion of such
bodies in the list of CAB's in subpart B of this part:
(a) The designating authority identified in subpart B of this part
shall designate CAB's in accordance with the procedures and criteria
set forth in subpart B of this part;
(b) A party proposing to add a CAB to the list of such bodies in
subpart B of this part shall forward its proposal of one or more
designated CAB's in writing to the other party with a view to a
decision by the Joint Committee;
(c) Within 60 days following receipt of the proposal, the other
party shall indicate its position regarding either its confirmation or
its opposition. Upon confirmation, the inclusion in subpart B of this
part of the proposed CAB or CAB's shall take effect; and
(d) In the event that the other party contests on the basis of
documented evidence the technical competence or compliance of a
proposed CAB, or indicates in writing that it requires an additional 30
days to more fully verify such evidence, such CAB shall not be included
on the list of CAB's in subpart B of this part. In this instance, the
Joint Committee may decide that the body concerned be verified. After
the completion of such verification, the proposal to list the CAB in
subpart B may be resubmitted to the other party.
Sec. 26.67 Suspension of listed conformity assessment bodies.
The following procedures shall apply with regard to the suspension
of a conformity assessment body (CAB) listed in subpart B of this part.
(a) A party shall notify the other party of its contestation of the
technical competence or compliance of a CAB listed in subpart B of this
part and the contesting party's intent to suspend such CAB. Such
contestation shall be exercised when justified in an objective and
reasoned manner in writing to the other party;
(b) The CAB shall be given prompt notice by the other party and an
opportunity to present information in order to refute the contestation
or to correct the deficiencies which form the basis of the
contestation;
(c) Any such contestation shall be discussed between the parties in
the Joint Sectoral Committee described in subpart B of this part. If
there is no Joint Sectoral Committee, the contesting party shall refer
the matter directly to the Joint Committee. If agreement to suspend is
reached by the Joint Sectoral Committee or, if there is no Joint
Sectoral Committee, by the Joint Committee, the CAB shall be suspended;
(d) Where the Joint Sectoral Committee or Joint Committee decides
that verification of technical competence or compliance is required, it
shall normally be carried out in a timely manner by the party in whose
territory the body in question is located, but may be carried out
jointly by the parties in justified cases;
(e) If the matter has not been resolved by the Joint Sectoral
Committee within 10 days of the notice of contestation, the matter
shall be referred to the Joint Committee for a decision. If there is no
Joint Sectoral Committee, the matter shall be referred directly to the
Joint Committee. If no decision is reached by the Joint Committee
within 10 days of the referral to it, the CAB shall be suspended upon
the request of the contesting party;
(f) Upon the suspension of a CAB listed in subpart B of this part,
a party is no longer obligated to accept or recognize the results of
conformity assessment procedures performed by that CAB subsequent to
suspension. A party shall continue to accept the results of conformity
assessment procedures performed by that CAB prior to suspension, unless
a regulatory authority of the party decides otherwise based on health,
safety or environmental considerations or failure to satisfy other
requirements within the scope of subpart B of this part; and
(g) The suspension shall remain in effect until agreement has been
reached by the parties upon the future status of that body.
Sec. 26.68 Withdrawal of listed conformity assessment bodies.
The following procedures shall apply with regard to the withdrawal
from subpart B of this part of a conformity assessment body (CAB):
(a) A party proposing to withdraw a CAB listed in subpart B of this
part shall forward its proposal in writing to the other party;
(b) Such CAB shall be promptly notified by the other party and
shall be provided a period of at least 30 days from receipt to provide
information in order to refute or to correct the deficiencies which
form the basis of the proposed withdrawal;
(c) Within 60 days following receipt of the proposal, the other
party shall indicate its position regarding either its confirmation or
its opposition. Upon confirmation, the withdrawal from the list in
subpart B of this part of the CAB shall take effect;
(d) In the event the other party opposes the proposal to withdraw
by supporting the technical competence and compliance of the CAB, the
CAB shall not at that time be withdrawn from the list of CAB's in
subpart B of this part. In this instance, the Joint Sectoral Committee
or the Joint Committee may decide to carry out a joint verification of
the body concerned. After the completion of such verification, the
proposal for withdrawal of the CAB may be resubmitted to the other
party; and
(e) Subsequent to the withdrawal of a CAB listed in subpart B of
this part, a party shall continue to accept the results of conformity
assessment procedures performed by that CAB prior to withdrawal, unless
a regulatory authority of the party decides otherwise based on health,
safety, and environmental considerations or failure to satisfy other
requirements within the scope of subpart B of this part.
[[Page 17770]]
Sec. 26.69 Monitoring of conformity assessment bodies.
The following shall apply with regard to the monitoring of
conformity assessment bodies (CAB's) listed in subpart B of this part:
(a) Designating authorities shall assure that their CAB's listed in
subpart B of this part are capable and remain capable of properly
assessing conformity of products or processes, as applicable, and as
covered in subpart B of this part. In this regard, designating
authorities shall maintain, or cause to maintain, ongoing surveillance
over their CAB's by means of regular audit or assessment;
(b) The parties undertake to compare methods used to verify that
the CAB's listed in subpart B of this part comply with the relevant
requirements of subpart B of this part. Existing systems for the
evaluation of CAB's may be used as part of such comparison procedures;
(c) Designating authorities shall consult as necessary with their
counterparts, to ensure the maintenance of confidence in conformity
assessment procedures. With the consent of both parties, this
consultation may include joint participation in audits/inspections
related to conformity assessment activities or other assessments of
CAB's listed in subpart B of this part; and
(d) Designating authorities shall consult, as necessary, with the
relevant regulatory authorities of the other party to ensure that all
technical requirements are identified and are satisfactorily addressed.
Sec. 26.70 Conformity assessment bodies.
Each party recognizes that the conformity assessment bodies (CAB's)
listed in subpart B of this part fulfill the conditions of eligibility
to assess conformity in relation to its requirements as specified in
subpart B of this part. The parties shall specify the scope of the
conformity assessment procedures for which such bodies are listed.
Sec. 26.71 Exchange of information.
(a) The parties shall exchange information concerning the
implementation of the legislative, regulatory, and administrative
provisions identified in subparts A and B of this part.
(b) Each party shall notify the other party of legislative,
regulatory, and administrative changes related to the subject matter of
this part at least 60 days before their entry into force. Where
considerations of safety, health or environmental protection require
more urgent action, a party shall notify the other party as soon as
practicable.
(c) Each party shall promptly notify the other party of any changes
to its designating authorities and/or conformity assessment bodies
(CAB's).
(d) The parties shall exchange information concerning the
procedures used to ensure that the listed CAB's under their
responsibility comply with the legislative, regulatory, and
administrative provisions outlined in subpart B of this part.
(e) Regulatory authorities identified in subparts A and B of this
part shall consult as necessary with their counterparts, to ensure the
maintenance of confidence in conformity assessment procedures and to
ensure that all technical requirements are identified and are
satisfactorily addressed.
Sec. 26.72 Sectoral contact points.
Each party shall appoint and confirm in writing contact points to
be responsible for activities under subparts A and B of this part.
Sec. 26.73 Joint Committee.
(a) A Joint Committee consisting of representatives of the United
States and the European Community (EC) will be established. The Joint
Committee shall be responsible for the effective functioning of this
part.
(b) The Joint Committee may establish Joint Sectoral Committees
comprised of appropriate regulatory authorities and others deemed
necessary.
(c) The United States and the EC shall have one vote in the Joint
Committee. The Joint Committee shall make its decisions by unanimous
consent. The Joint Committee shall determine its own rules and
procedures.
(d) The Joint Committee may consider any matter relating to the
effective functioning of this part. In particular it shall be
responsible for:
(1) Listing, suspension, withdrawal and verification of conformity
assessment bodies (CAB's) in accordance with this subpart and subpart B
of this part;
(2) Amending transitional arrangements in subparts A and B of this
part;
(3) Resolving any questions relating to the application of this
part not otherwise resolved in the respective Joint Sectoral
Committees;
(4) Providing a forum for discussion of issues that may arise
concerning the implementation of this part;
(5) Considering ways to enhance the operation of this part;
(6) Coordinating the negotiation of additional subparts; and
(7) Considering whether to amend this part in accordance with
Sec. 26.80.
(e) When a party introduces new or additional conformity assessment
procedures affecting subpart A or B of this part, the parties shall
discuss the matter in the Joint Committee with a view to bringing such
new or additional procedures within the scope of this part, where
relevant.
Sec. 26.74 Preservation of regulatory authority.
(a) Nothing in this part shall be construed to limit the authority
of a party to determine, through its legislative, regulatory, and
administrative measures, the level of protection it considers
appropriate for safety; for protection of human, animal, or plant life
or health; for the environment; for consumers; and otherwise with
regard to risks within the scope of the applicable subpart A or B of
this part.
(b) Nothing in this part shall be construed to limit the authority
of a regulatory authority to take all appropriate and immediate
measures whenever it ascertains that a product may:
(1) Compromise the health or safety of persons in its territory;
(2) Not meet the legislative, regulatory, or administrative
provisions within the scope of the applicable subpart A or B of this
part; or
(3) Otherwise fail to satisfy a requirement within the scope of the
applicable subpart A or B of this part. Such measures may include
withdrawing the products from the market, prohibiting their placement
on the market, restricting their free movement, initiating a product
recall, and preventing the recurrence of such problems, including
through a prohibition on imports. If the regulatory authority takes
such action, it shall inform its counterpart authority and the other
party within 15 days of taking such action, providing its reasons.
Sec. 26.75 Suspension of recognition obligations.
Either party may suspend its obligations under subpart A or B of
this part, in whole or in part, if:
(a) A party suffers a loss of market access for the party's
products within the scope of subpart A or B of this part as a result of
the failure of the other party to fulfill its obligations under this
part;
(b) The adoption of new or additional conformity assessment
requirements as referenced in Sec. 26.73(e) results in a loss of market
access for the party's products within the scope of subpart B of this
part because conformity assessment bodies (CAB's) designated by the
party in order to meet such requirements have not been recognized by
the party implementing the requirements; or
[[Page 17771]]
(c) The other party fails to maintain legal and regulatory
authorities capable of implementing the provisions of this part.
Sec. 26.76 Confidentiality.
(a) Each party agrees to maintain, to the extent required under its
laws, the confidentiality of information exchanged under this part.
(b) In particular, neither party shall disclose to the public, nor
permit a conformity assessment body (CAB) to disclose to the public,
information exchanged under this part that constitutes trade secrets,
confidential commercial or financial information, or information that
relates to an ongoing investigation.
(c) A party or a CAB may, upon exchanging information with the
other party or with a CAB of the other party, designate the portions of
the information that it considers to be exempt from disclosure.
(d) Each party shall take all precautions reasonably necessary to
protect information exchanged under this part from unauthorized
disclosure.
Sec. 26.77 Fees.
Each party shall endeavor to ensure that fees imposed for services
under this part shall be commensurate with the services provided. Each
party shall ensure that, for the sectors and conformity assessment
procedures covered under this part, it shall charge no fees with
respect to conformity assessment services provided by the other party.
Sec. 26.78 Agreements with other countries.
Except where there is written agreement between the parties,
obligations contained in mutual recognition agreements concluded by
either party with a party not a party to this part (a third party)
shall have no force and effect with regard to the other party in terms
of acceptance of the results of conformity assessment procedures in the
third party.
Sec. 26.79 Territorial application.
This part shall apply, on the one hand, to the territories in which
the Treaty establishing the European Community (EC) is applied, and
under the conditions laid down in that Treaty and, on the other hand,
to the territory of the United States.
Sec. 26.80 Entry into force, amendment and termination.
(a) The ``Agreement on Mutual Recognition Between the United States
of America and the European Community,'' from which this part is
derived, including its sectoral annexes on telecommunications
equipment, electromagnetic compatibility, electrical safety,
recreational craft, pharmaceutical GMP inspections, and medical devices
shall enter into force on the first day of the second month following
the date on which the parties have exchanged letters confirming the
completion of their respective procedures for the entry into force of
that agreement.
(b) That agreement including any sectoral annex may, through the
Joint Committee, be amended in writing by the parties to that
agreement. Those parties may add a sectoral annex upon the exchange of
letters. Such annex shall enter into force 30 days following the date
on which those parties have exchanged letters confirming the completion
of their respective procedures for the entry into force of the sectoral
annex.
(c) Either party to that agreement may terminate that agreement in
its entirety or any individual sectoral annex thereof by giving the
other party to that agreement 6 months notice in writing. In the case
of termination of one or more sectoral annexes, the parties to that
agreement will seek to achieve by consensus to amend that agreement,
with a view to preserving the remaining Sectoral Annexes, in accordance
with the procedures in this section. Failing such consensus, that
agreement shall terminate at the end of 6 months.
(d) Following termination of that agreement in its entirety or any
individual sectoral annex thereof, a party to that agreement shall
continue to accept the results of conformity assessment procedures
performed by conformity assessment bodies under that agreement prior to
termination, unless a regulatory authority in the party decides
otherwise based on health, safety and environmental considerations or
failure to satisfy other requirements within the scope of the
applicable sectoral annex.
Sec. 26.81 Final provisions.
(a) The sectoral annexes referred to in Sec. 26.80(a), as well as
any new sectoral annexes added pursuant to Sec. 26.80(b), shall form an
integral part of the ``Agreement on Mutual Recognition Between the
United States of America and the European Community,'' from which this
part is derived.
(b) For a given product or sector, the provisions contained in
subparts A and B of this part shall apply in the first place, and the
provisions of subpart C of this part in addition to those provisions.
In the case of any inconsistency between the provisions of subpart A or
B of this part and subpart C of this part, subpart A or B shall
prevail, to the extent of that inconsistency.
(c) The agreement from which this part is derived shall not affect
the rights and obligations of the parties under any other international
agreement.
(d) In the case of subpart B of this part, the parties shall review
the status of such subpart at the end of 3 years from entry into force
of subpart B.
Dated: April 6, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-9486 Filed 4-9-98; 8:45 am]
BILLING CODE 4160-01-F
